Heart valve sealing devices and delivery devices therefor

ABSTRACT

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion, wherein the prosthetic device is movable between a compressed configuration, in which the spacer body portion is radially compressed and is axially spaced relative to the anchor portion, and an expanded configuration, in which the spacer body portion expands radially outwardly relative to the compressed configuration and overlaps at least a portion of the anchor portion.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/161,688, filed on May 14, 2015, which is incorporated herein byreference.

FIELD

This disclosure pertains generally to prosthetic devices and relatedmethods for helping to seal native heart valves and prevent or reduceregurgitation therethrough, as well as devices and related methods forimplanting such prosthetic devices.

BACKGROUND

The native heart valves (i.e., the aortic, pulmonary, tricuspid andmitral valves) serve critical functions in assuring the forward flow ofan adequate supply of blood through the cardiovascular system. Theseheart valves can be damaged, and thus rendered less effective, bycongenital malformations, inflammatory processes, infectious conditions,or disease. Such damage to the valves can result in seriouscardiovascular compromise or death. For many years the definitivetreatment for such damaged valves was surgical repair or replacement ofthe valve during open heart surgery. However, open heart surgeries arehighly invasive and are prone to many complications. Therefore, elderlyand frail patients with defective heart valves often went untreated.More recently, transvascular techniques have been developed forintroducing and implanting prosthetic devices in a manner that is muchless invasive than open heart surgery. One particular transvasculartechnique that is used for accessing the native mitral and aortic valvesis the transseptal technique. The transseptal technique comprisesinserting a catheter into the right femoral vein, up the inferior venacava and into the right atrium. The septum is then punctured and thecatheter passed into the left atrium. Such transvascular techniques haveincreased in popularity due to their high success rates.

A healthy heart has a generally conical shape that tapers to a lowerapex. The heart is four-chambered and comprises the left atrium, rightatrium, left ventricle, and right ventricle. The left and right sides ofthe heart are separated by a wall generally referred to as the septum.The native mitral valve of the human heart connects the left atrium tothe left ventricle. The mitral valve has a very different anatomy thanother native heart valves. The mitral valve includes an annulus portion,which is an annular portion of the native valve tissue surrounding themitral valve orifice, and a pair of cusps, or leaflets, extendingdownward from the annulus into the left ventricle. The mitral valveannulus can form a “D”-shaped, oval, or otherwise out-of-roundcross-sectional shape having major and minor axes. The anterior leafletcan be larger than the posterior leaflet, forming a generally “C”-shapedboundary between the abutting free edges of the leaflets when they areclosed together.

When operating properly, the anterior leaflet and the posterior leafletfunction together as a one-way valve to allow blood to flow only fromthe left atrium to the left ventricle. The left atrium receivesoxygenated blood from the pulmonary veins. When the muscles of the leftatrium contract and the left ventricle dilates (also referred to as“ventricular diastole” or “diastole”), the oxygenated blood that iscollected in the left atrium flows into the left ventricle. When themuscles of the left atrium relax and the muscles of the left ventriclecontract (also referred to as “ventricular systole” or “systole”), theincreased blood pressure in the left ventricle urges the two leafletstogether, thereby closing the one-way mitral valve so that blood cannotflow back to the left atrium and is instead expelled out of the leftventricle through the aortic valve. To prevent the two leaflets fromprolapsing under pressure and folding back through the mitral annulustoward the left atrium, a plurality of fibrous cords called chordaetendineae tether the leaflets to papillary muscles in the leftventricle.

Mitral regurgitation occurs when the native mitral valve fails to closeproperly and blood flows into the left atrium from the left ventricleduring the systolic phase of heart contraction. Mitral regurgitation isthe most common form of valvular heart disease. Mitral regurgitation hasdifferent causes, such as leaflet prolapse, dysfunctional papillarymuscles and/or stretching of the mitral valve annulus resulting fromdilation of the left ventricle. Mitral regurgitation at a centralportion of the leaflets can be referred to as central jet mitralregurgitation and mitral regurgitation nearer to one commissure (i.e.,location where the leaflets meet) of the leaflets can be referred to aseccentric jet mitral regurgitation.

Some prior techniques for treating mitral regurgitation includestitching portions of the native mitral valve leaflets directly to oneanother. Other prior techniques include the use of a spacer implantedbetween the native mitral valve leaflets. Despite these priortechniques, there is a continuing need for improved devices and methodsfor treating mitral valve regurgitation.

SUMMARY

Described herein are embodiments of prosthetic devices that areprimarily intended to be implanted at one of the mitral, aortic,tricuspid, or pulmonary valve regions of a human heart, as well asapparatuses and methods for implanting the same. The prosthetic devicescan be used to help restore and/or replace the functionality of adefective native mitral valve.

In one representative embodiment, an implantable prosthetic devicecomprises a spacer body portion configured to be disposed between nativeleaflets of a heart, and an anchor portion configured to secure thenative leaflets against the spacer body portion, wherein the prostheticdevice is movable between a compressed configuration, in which thespacer body portion is radially compressed and is axially spacedrelative to the anchor portion, and an expanded configuration, in whichthe spacer body portion expands radially outwardly relative to thecompressed configuration and overlaps at least a portion of the anchorportion.

In some embodiments, the anchor portion includes a plurality of anchormembers, and the anchor members are each configured to secure arespective native leaflet against the spacer body portion. In some ofthose embodiments, the anchor members each have a first portion, asecond portion, and a joint portion disposed between the first portionand the second portion, and wherein the first portions are spacedrelative to the second portions in the compressed configuration andoverlap with the second portions in the expanded configuration.

In some embodiments, the prosthetic device further comprising an endmember axially spaced from and movable relative to the spacer bodyportion, wherein the first portions of the anchor members are pivotablycoupled to an end portion of the spacer body portion, the secondportions of the anchor members are pivotably coupled to the end member,and the anchor members are configured to be foldable at the jointportions when the spacer body portion is moved relative to the endmember. In some embodiments, the anchor members are configured to foldat the joint portions from the compressed configuration to the expandedconfiguration when the spacer body portion is moved relatively closer tothe end member, and the anchor members are configured to unfold at thejoint portions from the expanded configuration to the compressedconfiguration when the spacer body portion is moved relatively fartherfrom the end member.

In some embodiments, the prosthetic device further comprises a securingmember having barbs coupled to one of the anchor members, wherein thesecuring member is configured to engage native leaflet tissue and tosecure the native leaflet tissue to the one of the anchor members. Insome of those embodiments, the securing member is pivotably coupled tothe spacer body portion and the anchor portion.

In some embodiments, the anchor members are movable relative to eachother. In some embodiments, the spacer body portion and the anchorportion are formed from a single, unitary piece of braided material. Insome embodiments, the braided material comprises Nitinol. In someembodiments, the spacer body portion and the anchor portion areself-expandable. In some embodiments, the prosthetic device isconfigured for implantation in a native mitral valve and to reducemitral regurgitation.

In another representative embodiment, an assembly is provided. Theassembly comprises an implantable prosthetic device having a spacer bodyand a plurality of anchors, wherein first end portions of the anchorsare coupled to a first end portion of the spacer body, and a deliveryapparatus having a first shaft and a second shaft, wherein the firstshaft and the second shaft are moveable relative to each other, whereinsecond end portions of the anchors are releasably coupled to the firstshaft, and a second end portion of the spacer body is releasably coupledto the second shaft, wherein delivery apparatus is configured such thatmoving the first shaft and the second shaft relative to each moves theprosthetic device between a first configuration, in which the spacerbody is radially compressed and is axially spaced relative to theanchors, and a second configuration, in which the spacer body expandsradially outwardly relative to the compressed configuration and theanchors at least partially overlap the spacer body to capture nativeleaflets between the anchors and the spacer body.

In some embodiments, the first shaft of the delivery apparatus extendsthrough the second shaft of the delivery apparatus and the spacer bodyof the prosthetic device, and the first shaft is axially movablerelative to the spacer body. In some embodiments, the first shaft of thedelivery apparatus is a plurality of anchor shafts, and each of theanchor shafts is releasably coupled to a respective anchor of theprosthetic device and is movable relative to other ones of the anchorshafts.

In some embodiments, the anchors each have a first portion, a secondportion, and a joint portion disposed between the first portion and thesecond portion, and the first portion is spaced relative to the secondportion in the first configuration and overlaps with the second portionin the second configuration. In some embodiments, the prosthetic devicefurther comprises an end member spaced from and movable relative to thespacer body, wherein the first portions of the anchors are pivotablycoupled to an end portion of the spacer body, the second portions of theanchors are pivotably coupled to the end member, and the anchors fold atthe joint portions when the spacer body is moved relative to the endmember. In some embodiments, the anchors fold at the joint portions fromthe compressed configuration to the expanded configuration when thespacer body moves relatively closer to the end member, and the anchorsunfold at the joint portions from the expanded configuration to thecompressed configuration when the spacer body portion moves relativelyfarther from the end member.

In some embodiments, the prosthetic device further comprises securingmembers having barbs coupled to the anchors and configured to engagenative leaflet tissue to secure the anchors to native leaflets.

In another representative embodiment, a method of implanting aprosthetic device is provided. The method comprises advancing aprosthetic device in a compressed configuration to an implantationlocation using a delivery apparatus, wherein the prosthetic devicecomprises a spacer body, a first anchor, and a second anchor, radiallyexpanding the prosthetic device from the compressed configuration to anexpanded configuration, capturing a first native leaflet between twosurfaces of the first anchor, capturing a second native leaflet betweentwo surfaces of the second anchor, securing the first native leaflet andthe second native leaflet against the spacer body of the prostheticdevice, and releasing the prosthetic device from the delivery apparatus.

In some embodiments, the act of capturing the first native leafletoccurs prior to the act of capturing the second native leaflet, and theact of capturing the second native leaflet occurs prior to the act ofsecuring the first native leaflet and the second native leaflet againstthe spacer body of the prosthetic device. In some embodiments, the actof capturing the first native leaflet occurs by actuating a first memberof the delivery apparatus, and the act of capturing the second nativeleaflet occurs by actuating a second member of the delivery apparatus.In some embodiments, the first native leaflet and the second nativeleaflet are secured against the spacer body of the prosthetic device bymoving a first shaft of the delivery apparatus relative to the secondshaft of the delivery apparatus.

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 show an implantable prosthetic device, according to oneembodiment, in various stages of deployment.

FIGS. 4-5 show an implantable prosthetic device, according to anotherembodiment, in various stages of deployment.

FIGS. 6-8 show an implantable prosthetic device being delivered andimplanted within the native mitral valve, according to one embodiment.

FIGS. 9-12 show various views of another embodiment of an implantableprosthetic device.

FIGS. 13-17 show the prosthetic device of FIGS. 9-12 being delivered andimplanted within the native mitral valve.

FIG. 18 is a side view of another embodiment of an implantableprosthetic device.

FIGS. 19a-19h show an exemplary heat-shaping process that can be used toform a prosthetic device, such as those shown in FIGS. 9-12 or FIG. 18.

FIGS. 20-24 show various views of another embodiment of an implantableprosthetic device.

FIGS. 25-26 are side views of another embodiment of an implantableprosthetic device.

FIGS. 27-34 show various views of the prosthetic device of FIGS. 25-26at different stages of deployment.

FIG. 35 shows another embodiment of an implantable prosthetic devicebeing implanted within the native mitral valve.

FIG. 36 shows another embodiment of an implantable prosthetic devicebeing implanted within the native mitral valve.

FIGS. 37-47 show various views of another embodiment of an implantableprosthetic device.

FIGS. 48-52 show various views of another embodiment of an implantableprosthetic device.

FIG. 53 shows another embodiment of an implantable prosthetic device.

FIGS. 54-58 show the prosthetic device of FIG. 53 at various stages ofdeployment within the native mitral valve.

FIGS. 59-61 show various views of another embodiment of an implantableprosthetic device in different stages of deployment.

FIG. 62 is a side of a steerable delivery device for an implantableprosthetic device, according to one embodiment.

FIGS. 63a and 63b are end and side views, respectively, of an expandablebasket portion of the delivery device of FIG. 62.

FIG. 64 is a side view of the basket portion of FIGS. 63a and 63b shownin an expanded configuration.

FIGS. 65a and 65b are end and side views, respectively, of theintermediate shaft of the delivery device of FIG. 62.

FIG. 66 is a cross-sectional view of the proximal shaft of the deliverydevice of FIG. 62.

FIG. 67 shows the delivery of a prosthetic device to the native mitralvalve using the delivery device of FIG. 62.

FIG. 68 is a side of a steerable delivery device for an implantableprosthetic device, according to another embodiment.

FIG. 69 is a perspective, exploded view of the delivery device of FIG.68.

FIGS. 70a-71b show various views of a slotted metal tube that can beincorporated in the inner steerable shaft of the delivery device of FIG.68.

FIGS. 72-74 show various views of an alternative embodiment of asteering control member that can be incorporated in a delivery device.

FIG. 75 is a cross-sectional view of another embodiment of a steeringcontrol member that can be incorporated in a delivery device.

FIGS. 76-79 show various views of an alternative embodiment of asteering control member that can be incorporated in a delivery device.

FIGS. 80-82 show various views of an alternative embodiment of asteering control member that can be incorporated in a delivery device.

FIGS. 83-85 show various views of an alternative embodiment of asteering control member that can be incorporated in a delivery device.

FIGS. 86-87 are end and side views, respectively, of a catheter-positionlocking device, according to one embodiment.

FIGS. 88-91 show various views of another embodiment of acatheter-position locking device.

FIGS. 92-96 show various views of another embodiment of acatheter-position locking device.

FIGS. 97-98 are perspective and end views, respectively, of anotherembodiment of a catheter-position locking device.

FIGS. 99-102 are various views of another embodiment of a deliverydevice being used to deliver a prosthetic device within the nativemitral valve.

FIG. 103 is a perspective view of an exemplarycollet/prosthetic-device-retaining-mechanism that can be incorporated inthe delivery device of FIGS. 99-102.

FIGS. 104-106 show various views of a prosthetic device being connectedto a delivery device for delivery into a patient.

FIGS. 107-110 are various views of another embodiment of a deliverydevice being used to deliver a prosthetic device within the nativemitral valve.

FIG. 111 is a perspective view of an exemplarycollet/prosthetic-device-retaining-mechanism that can be incorporated inthe delivery device of FIGS. 107-110.

FIG. 112 is a cross-sectional view of an exemplary embodiment of anon-circular shaft of a delivery device.

FIG. 113 is a cross-sectional view of another exemplary embodiment of anon-circular shaft of a delivery device.

FIG. 114 shows another exemplary embodiment of an implantable prostheticdevice.

FIG. 115 shows another exemplary embodiment of an implantable prostheticdevice.

FIG. 116 shows another exemplary embodiment of an implantable prostheticdevice.

FIG. 117 shows an exemplary embodiment of an anchor that can beincorporated in an implantable prosthetic device.

FIG. 118 shows another exemplary embodiment of an implantable prostheticdevice.

FIGS. 119A-119F show another exemplary embodiment of an implantableprosthetic device.

FIGS. 120A-120C show another exemplary embodiment of an implantableprosthetic device.

FIGS. 121A-121D show another exemplary embodiment of an implantableprosthetic device.

FIGS. 122A-122D show another exemplary embodiment of an implantableprosthetic device.

FIGS. 123A-123D show another exemplary embodiment of an implantableprosthetic device.

FIGS. 124A-124F show the prosthetic device of FIGS. 123A-123D in variousstages of deployment.

FIGS. 125A-125E show another exemplary embodiment of an implantableprosthetic device.

FIGS. 26A-126J show another exemplary embodiment of an implantableprosthetic device.

FIGS. 127A-127F show another exemplary embodiment of an implantableprosthetic device.

FIG. 128 shows an alternative embodiment of a steering control mechanismfor a delivery device.

FIGS. 129-130 show another exemplary embodiment of an implantableprosthetic device.

FIGS. 131-133 show an exemplary embodiment of an implantable prostheticheart valve.

FIGS. 134-135 show an exemplary embodiment of a frame for an implantableprosthetic heart valve.

DETAILED DESCRIPTION

Described herein are embodiments of prosthetic devices that areprimarily intended to be implanted at one of the mitral, aortic,tricuspid, or pulmonary valve regions of a human heart, as well asapparatuses and methods for implanting the same. The prosthetic devicescan be used to help restore and/or replace the functionality of adefective native mitral valve. The disclosed embodiments should not beconstrued as limiting in any way. Instead, the present disclosure isdirected toward all novel and nonobvious features and aspects of thevarious disclosed embodiments, alone and in various combinations andsub-combinations with one another.

Prosthetic Spacers

A prosthetic spacer device comprises a spacer body and at least oneanchor. The body is configured to be positioned within the native mitralvalve orifice to help create a more effective seal between the nativeleaflets to prevent or minimize mitral regurgitation. The body cancomprise a structure that is impervious to blood and that allows thenative leaflets to close around the sides of the body during ventricularsystole to block blood from flowing from the left ventricle back intothe left atrium. The body is sometimes referred to herein as a spacerbecause the body can fill a space between improperly functioning nativemitral leaflets that do not naturally close completely.

The body can have various shapes. In some embodiments, the body can havean elongated cylindrical shape having a round cross-sectional shape. Inother embodiments, the body can have an ovular cross-sectional shape, acrescent cross-sectional shape, or various other non-cylindrical shapes.The body can have an atrial or upper end positioned in or adjacent tothe left atrium, a ventricular or lower end positioned in or adjacent tothe left ventricle, and an annular side surface that extends between thenative mitral leaflets.

The anchor can be configured to secure the device to one or both of thenative mitral leaflets such that the body is positioned between the twonative leaflets. In some embodiments, the anchor can attach to the bodyat a location adjacent the ventricular end of the body. In someembodiments, the anchor can attach to a shaft, to which the body is alsoattached. In some embodiments, the anchor and the body can be positionedindependently with respect to each by separately moving each the anchorand the body along the longitudinal axis of the shaft. In someembodiments, the anchor and the body can be positioned simultaneously bymoving the anchor and the body together along the longitudinal axis ofthe shaft. The anchor can be configured to be positioned behind a nativeleaflet when implanted such that the leaflet is captured between theanchor and the body.

The prosthetic device can be configured to be implanted via a deliverysheath. The body and the anchor can be compressible to a radiallycompressed state and can be self-expandable to a radially expanded statewhen compressive pressure is released. The device can be configured toallow the anchor to self-expand radially away from the still-compressedbody initially in order to create a gap between the body and the anchor.A native leaflet can then be positioned in the gap. The body can then beallowed to self-expand radially, closing the gap between the body andthe anchor and capturing the leaflet between the body and the anchor.The implantation methods for various embodiments can be different, andare more fully discussed below with respect to each embodiment.Additional information regarding these and other delivery methods can befound in U.S. Pat. No. 8,449,599 and U.S. Patent Application PublicationNos. 2014/0222136, and 2014/0067052, each of which is incorporatedherein by reference in its entirety.

Some embodiments disclosed herein are generally configured to be securedto both the anterior and posterior native mitral leaflets. However,other embodiments comprise only one anchor and can be configured to besecured to one of the mitral leaflets. Unless otherwise stated, any ofthe embodiments disclosed herein that comprise a single anchor canoptionally be secured to the anterior mitral leaflet or secured to theposterior mitral leaflet, regardless of whether the particularembodiments are shown as being secured to a particular one of theleaflets.

Some of the disclosed prosthetic devices are prevented from atrialembolization by having the anchor hooked around a leaflet, utilizing thetension from native chordae tendineae to resist high systolic pressureurging the device toward the left atrium. During diastole, the devicescan rely on the compressive forces exerted on the leaflet that iscaptured between the body and the anchor to resist embolization into theleft ventricle.

FIGS. 1-3 show an implantable prosthetic device 10, according to oneembodiment. The prosthetic device 10 in the illustrated embodimentcomprises a ventricular portion 12, a spacer body 14, and an inner shaft16 on which the ventricular portion 12 and the spacer body 14 aremounted. The ventricular portion 12 includes a collar 18 disposed on theshaft 16 and one or more ventricular anchors 20 (two in the illustratedembodiment) extending from the collar 18. An end cap 22 can be mountedto the distal end of the shaft 16 to retain the ventricular portion 12on the shaft.

The proximal end of the spacer body 14 is secured to a collar or nut 24,which is disposed on the shaft 16 proximal to the spacer body 14. Thus,the shaft 16 extends co-axially through the collar 24, the spacer body14 and the collar 18 of the ventricular portion 12. The device 10 canfurther include an outer shaft or sleeve 26 that extends co-axially overa proximal end portion of the inner shaft 16 and is attached at itsdistal end to the collar 24. The inner shaft 16 is rotatable relative tothe outer shaft 26 and the spacer body 14 to effect axial movement ofthe spacer body along the inner shaft 16 toward and away from theventricular portion 12, as further described below.

The spacer body 14 can comprise an annular metal frame 28 (FIG. 3)covered with a blood-impervious fabric 30 (FIGS. 1 and 2). FIG. 3 showsthe spacer body 14 without the blood-impervious fabric 30 covering theframe 28. The frame 24 can comprise a mesh-like structure comprising aplurality of interconnected metal struts, like a conventional radiallycompressible and expandable stent. In the illustrated configuration, theframe 28 has a generally spherical shape, although the frame can havevarious other shapes in other alternative embodiments (e.g.,cylindrical, conical, etc.). In other embodiments, the body can comprisea solid block of material, such as flexible, sponge-like and/orelastomeric block of material formed, for example, from a biocompatiblepolymer, such silicone.

The frame 24 can be formed from a self-expandable material, such asNitinol. When formed from a self-expandable material, the frame 24 canbe radially compressed to a delivery configuration and can be retainedin the delivery configuration by placing the device in the sheath of adelivery apparatus. When deployed from the sheath, the frame 24 canself-expand to its functional size. In other embodiments, the frame canbe formed from a plastically expandable material, such as stainlesssteel or a cobalt chromium alloy. When formed from a plasticallyexpandable material, the prosthetic device can be crimped onto adelivery apparatus and radially expanded to its functional size by aninflatable balloon or an equivalent expansion mechanism. It should benoted that any of the embodiments disclosed herein can comprise aself-expandable main body or a plastically expandable main body.

The inner shaft 16 can, for example, comprise a screw having externalthreads or a helical coil (as shown in FIGS. 1-3). The collar 24 hasinternal threads that engage the individual turns of the coil or in thecase where the shaft comprises a screw, the external threads of thescrew. Thus, rotation of the inner shaft 16 relative to the outer shaft26 is effective to move the collar 24, and thus the spacer body 14,along the length of the shaft 16. Rotation of the inner shaft 16relative to the outer shaft 26 can be accomplished by rotating arotatable torque shaft of a delivery apparatus (such as shown in FIGS.6-8) that is releasably connected to the inner shaft 16. The deliveryapparatus can have a respective outer shaft that is releasably connectedto the outer 26 and configured to restrict rotation of the outer shaft26 while the inner shaft 16 is rotated by the torque shaft.

The device 10 can be delivered percutaneously to a native heart valve(e.g., the mitral valve) with a delivery apparatus. FIG. 1 shows thespacer body 14 in a pre-anchored, proximal position spaced from theventricular portion 12 prior to being mounted to the native leaflets ofthe mitral valve (the native leaflets are not shown in FIGS. 1-3). Theanchors 20 are positioned in the left ventricle behind the nativeleaflets (e.g., desirably at the A2 and P2 regions of the leaflets, asidentified by Carpentier nomenclature). The spacer body 14 is then movedtoward the ventricular portion 12 (such as by rotating the torque shaftof the delivery apparatus) to the position shown in FIG. 2 such that theleaflets are captured between anchors 20 and the spacer body 14.

When the device 10 is secured to both of the leaflets, it brings themcloser together around the spacer body 14. By so doing, the device 10decreases the overall area of the mitral valve orifice and divides themitral valve orifice into two orifices during diastole. Thus, the areathrough which mitral regurgitation can occur is reduced, leafletcoaptation can be initiated at the location of the body 14, and theleaflets can fully coapt more easily, thereby preventing or minimizingmitral regurgitation.

Due to the flexible nature of the body 14, the circumference and/orwidth/diameter of the spacer body 14 can be further expanded by urgingthe spacer body 14 against the ventricular portion 12 by rotation of theinner shaft 16. This action compresses the end portions of the body 14between the anchors collar 24 and the collar 12, thereby causing thebody 14 to foreshorten axially and the middle portion of the body 14 toexpand radially. Conversely, moving the body 14 away from theventricular portion 12 allows the body to contract radially.

The adjustability of device 10 provides several advantages over priordevices. For example, the device 10 can advantageously be used forvarying degrees of mitral regurgitation because the device 10 can beconfigured to correspond to a various coaptation lines by expanding orcontracting the body 14, thus reducing the need to manufacture multipledevices. Another advantage, for example, is that a physician can adjustthe body 14 during the initial implant placement procedure to thedesired configuration without extensive measuring and monitoring priorto the procedure. Whereas prior devices require extensive measuringprior to the placement procedure to ensure that a properly sized implantis selected, a physician can now adjust the size of the body 14 duringthe implant placement procedure by monitoring the procedure with anechocardiogram and adjusting the body 14 to the desired configurationand size.

The device 10 can also advantageously be adjusted subsequent to theinitial placement procedure to reposition, expand, or contract thedevice 10 to achieve an improved result over the initial configuration.Yet another advantage of device 10 is that the anchors 12 and the body14 can be positioned independently. This is advantageous over priorsystems because it is often difficult to align the anchors and the bodysimultaneously due to the movement of the leaflets during diastole andsystole.

The body 14 of device 10 can also be configured to address centraland/or eccentric jet mitral regurgitation. Such configurations cancomprise various sizes and/or geometries of the body 14.

FIGS. 4 and 5 show another exemplary embodiment of an implantableprosthetic device 100. The device 100 comprises one or more ventricularanchors 102 (two in the illustrated embodiment), a spacer body 104, athreaded shaft 106, a proximal nut 108 and a distal stop 116. The shaft106 extends co-axially through the body 104, the nut 108 and the stop116.

The body 104 can comprise a distal, first annular collar 110 disposedaround the shaft 106 and positioned towards the ventricular end of thebody 104 of the device 100, a proximal, second annular collar 112disposed around the shaft 106 and positioned towards the atrial end ofthe body 104 of the device 100, and a plurality of struts 114 extendingbetween the first and second collars 110, 112.

The struts 114 can each be fixedly secured to the first collar 110respective to first ends of the struts 114 and fixedly secured to thesecond collar 112 respective to second ends of the struts 114. Thestruts 114 can, for example, be fixedly secured to the collars 110, 112by forming the struts 114 and the collars 110, 112 from a single,unitary piece of material (e.g., laser cutting a metal tube). In otherembodiments, the struts 114 can, for example, be fixedly secured to thecollars 110, 112 by an adhesive, welding, fasteners, etc. The anchors102 are also fixedly secured to the distal collar 110, such as bywelding, fasteners, an adhesive, or by forming the anchors and thecollar from a single piece of material. Although not shown in FIGS. 4and 5, the body 104 can be covered with a blood-impervious cover (e.g.,a fabric), similar to the fabric 30 shown in FIGS. 1 and 2.

In the illustrated embodiment, the distal stop 116 can be fixed to theshaft 106 and functions to prevent distal movement of the distal collar110 along the shaft 106 (to the left in FIGS. 4 and 5). The proximalcollar 112 can be secured to the nut 108, which has internal threadsthat engage the external threads of the shaft 106. As such, rotation ofthe shaft 106 causes the nut 108, and therefore the proximal collar 112,to move toward and away from the distal collar 110, thereby radiallyexpanding and contracting, respectively, the struts 114.

The anchors 102 and the struts 114 can be formed from a self-expandablematerial, such as Nitinol. When formed from a self-expandable material,the anchors 102 and the struts 114 can be radially compressed to adelivery configuration and can be retained in the delivery configurationby placing the device in the sheath of a delivery apparatus. Whendeployed from the sheath, the anchors 102 can radially expand, creatinggaps between the anchors 102 and the struts 114, as shown in FIG. 4. Inthis configuration, the native leaflets of a heart valve can be placedin the gaps between the anchors 102 and the struts 114. The leaflets canthen be secured between the anchors 102 and the struts 114 by moving theproximal collar 112 axially along the shaft toward the distal collar 110through rotation of the shaft. As the proximal collar 112 is movedtoward the distal collar 110, the struts 114 are caused to buckle or bowaway from the longitudinal axis of shaft 106 toward the anchors 102 asshown in FIG. 5. The axial position of the proximal collar 112 can beadjusted until the anchors 102 and the struts 114 apply a clamping forceagainst opposite sides of the leaflets, such that the device 100maintains its position during diastole and systole, with respect to theleaflets.

Rotation of the shaft 106 relative to the nut 108 and the body 104 canbe accomplished by rotating a rotatable torque shaft of a deliveryapparatus (such as shown in FIGS. 6-8) that is releasably connected tothe shaft 106. The delivery apparatus can have a respective outer shaftthat is releasably connected to the nut 108 and configured to restrictrotation of the nut 108 while the shaft 106 is rotated by the torqueshaft.

The shaft 106 shown in FIGS. 4 and 5 comprises a rigid bolt; however,the shaft 106 can comprise a flexible screw or a flexible helical coilsimilar to the shaft 16 shown in FIGS. 1-3.

In alternative embodiments, the position of the entire body 104(including the proximal and distal collars 110, 112) can be adjustedaxially along the length of the shaft 106 (in which case stop 116 is notfixed to the shaft 106). The position of the body 104 along the shaftcan be accomplished by rotating the shaft 106 relative to the body, orvice versa. Once the desired position of the body 104 along the shaft106 is attained, a stop member 118 can be positioned along the shaft inan abutting relationship with respect to the stop 116 (stop member 118is shown spaced from the stop 116 in the figures) to prevent furtherdistal movement of the body 104 along the shaft. Further rotation of theshaft 106 causes the proximal collar 112 to move toward the distalcollar 110, causing the struts 114 to expand.

In another embodiment, a distal portion of the shaft 106 can be threadedin one direction and a proximal portion of the shaft 106 can be threadedin the opposite direction. The threads of the proximal portion of theshaft engage internal threads of the nut 108. The stop 116 similarly cancomprise a nut having internal threads engaging the threads of thedistal portion of the shaft. In this manner, rotation of the shaftrelative to the body 104 in a first direction causes the distal andproximal collars 110, 112 to move toward each other, and rotation of theshaft relative to the body 104 in a second direction (opposite the firstdirection) causes the distal and proximal collars 110, 112 to move awayfrom each other, similar to a turnbuckle.

FIGS. 6-8 show an implantable prosthetic device 200 according to anotherembodiment being deployed from a delivery apparatus 202 into the mitralvalve via a transseptal technique. The prosthetic device 200 cancomprise an expandable spacer body 204, one or more ventricular anchors206 (two in the illustrated embodiment) coupled to and extending from adistal end portion of the spacer body 204, a shaft 208 extending throughthe spacer body 204, and a nut 210 disposed on the shaft 208. The nut210 can have internal threads that engage external threads on the shaft208 and can be restricted from rotational movement such that rotation ofthe shaft 208 causes axial movement of the nut 210 along the length ofthe shaft 208.

The delivery apparatus 202 can comprise an outer catheter 212 and animplant catheter 214. The implant catheter 214 can comprise a deliverysheath 216, a nut support shaft 218, and a torque shaft 220. Prior toinsertion into the patient's body, the prosthetic device 200 can beconnected to the nut support shaft 218 and the torque shaft 220 andloaded into the delivery sheath 216. The outer catheter 212 can beadvanced through a femoral vein, the inferior vena cava, into the rightatrium, across the septum 222 and into the left atrium 224 (as shown inFIG. 6). The outer catheter 212 can be advanced over a guide wire 226,which can be inserted into the patient's vasculature and used to crossthe septum 222 prior to introducing the outer catheter 212 into thepatient's body. As further shown in FIG. 6, the implant catheter 214,with the prosthetic device 200, can be inserted through the outercatheter 212 and into the left atrium 224. The implant catheter 214 canbe advanced across the native mitral valve leaflets 228 until theanchors 206 of the prosthetic device are in the left ventricle.

As shown in FIG. 7, the delivery sheath 216 can then be retracted toexpose the prosthetic device 200. The spacer body 204 can self-expand toa radially expanded state upon deployment from the delivery sheath 216.Alternatively, the spacer body 204 can be retained in a radiallycompressed state by the nut support shaft 218 when spacer body isdeployed from the sheath 216. After deploying the prosthetic device 200from the sheath 216, the torque shaft 220 can be rotated to open theanchors 206 to a desired position for capturing leaflets 226.

The anchors 206 can be positioned behind the leaflets 228 (e.g.,desirably at the A2 and P2 positions). The leaflets 228 can then besecured between the anchors 206 and the spacer body 204 by rotating thetorque shaft 220 and the shaft 208, causing the nut 210 to move axiallyalong the anchors 206 in the proximal direction. Movement of the nut 210is effective to urge the anchors 206 radially inwardly against theleaflets 228 (as shown in FIG. 8). Thus, the prosthetic device 200 canbe secured the leaflets 228 by clamping the leaflets 228 between theanchors 206 and the body 204. Thereafter, as shown in FIG. 8, the nutsupport shaft 218 and the torque catheter 220 can be released from theprosthetic device and the implant catheter can be retracted into theouter catheter.

FIG. 9 shows an exemplary implantable prosthetic device 300, accordingto another embodiment. The prosthetic device 300 in the illustratedembodiment comprises a ventricular portion 302, a spacer body 304, ashaft 306, and a proximal end 308. The ventricular end portion 302comprises one or more anchors 310 (two in the illustrated embodiment)extending from the ventricular end of the shaft 306. FIG. 9 also shows aguide wire 320 extending through the device 300. The guide wire 320 canbe used during the device placement procedure (described below).

As shown in FIG. 10, the device 300 can be formed from a single, unitarypiece of material. In some embodiments, the separate components of thedevice 300 can be formed from separate pieces of material that can befixedly secured together by an adhesive, welding, fasteners, etc. Thedevice 300 can be formed from a self-expandable braided material. Thebraided material can be formed from a metallic thread, such as Nitinol.When formed from a braided material, the device 300 can be covered witha blood-impervious cover (similar to the fabric 30 shown in FIGS. 1 and2) or coated with a flexible sealant material, such as expandedpolytetrafluoroethylene (commonly referred to as “ePTFE”), which allowsthe braided material to expand and/or bend while also preventing bloodflow through the device 300.

In the illustrated embodiment, the body 304 of device 300 has agenerally spherical shape, although the body 304 can have various othershapes in other embodiments (e.g., cylindrical, conical, etc.). The body304 of device 300 can also be configured to address central and/oreccentric jet mitral regurgitation. Such configurations can comprisevarious sizes and/or geometries of the body 304. As shown, the body 304of the device 300 can be an integral component of the device 300 formedfrom a single, unitary piece of self-expandable braided material, suchas braided Nitinol. In other embodiments, the body 304 can be formedfrom a separate piece of material, including a different material suchas a plastically expandable material or polymeric material (similar tothose materials described in reference to spacer body 14 above).

When formed from a self-expandable braided material, the device 300 canbe radially compressed to a delivery configuration (shown in FIG. 10)and can be retained in a delivery configuration by placing the device300 in a sheath of a delivery apparatus. The device 300 can be radiallycompressed by axially elongating the device 300 by unfolding the anchors310 such that the anchors 310 extend from the ventricular end of theshaft 306 away from the proximal end 308, parallel to the shaft 306, andby radially compressing the spacer body 304 to substantially the samediameter as the shaft 306, as shown in FIG. 10. With the device 300 inthe delivery configuration, device 300 can be delivered percutaneouslyto a native heart valve (e.g., the mitral valve) with the deliveryapparatus.

Once the device 300 is delivered percutaneously to a native heart valvewith a delivery apparatus, the delivery sheath can be removed from thedevice 300, which allows the device 300 to fold and expand to itsfunctional expanded state, shown in FIGS. 11 and 12. The native leaflets(not shown in FIGS. 11 and 12) are captured between anchors 310 and thespacer body 304 of the device 300, which brings them closer togetheraround the spacer body 304. By so doing, the device 300 decreases theoverall area of the mitral valve orifice and divides the mitral valveorifice into two orifices during diastole. Thus, the area through whichmitral regurgitation can occur is reduced, leaflet coaptation can beinitiated at the location of the body 304, and the leaflets can fullycoapt more easily, thereby preventing or minimizing mitralregurgitation.

For example, FIGS. 13-17 show the device 300 being delivered to themitral valve using a delivery apparatus 312. The delivery apparatus 312can comprise an outer catheter (not shown) and a device catheter 314.The device catheter 314 can comprise a delivery sheath 316 and a shaft318. Prior to insertion into the patient's body, the proximal end 308 ofthe device 300 can be releasably connected to the shaft 318 of thedevice catheter 314 and loaded into the delivery sheath 316, thusretaining the device 300 in the delivery configuration.

A guide wire 320 can be advanced through a patient's femoral vein, theinferior vena cava, into the right atrium, across the septum 322, intothe left atrium 324, across the mitral valve leaflets 326, and into theleft ventricle 328. The outer catheter can be advanced over the guidewire 320 and into the left atrium 324. The device catheter 314, with thedevice 300, can be advanced over the guide wire 320, through the outercatheter, and into to the left atrium 324. The device catheter 314 canbe advanced across the mitral valve leaflets 326 until the anchors 310of the device 300 are in the left ventricle 328.

As shown in FIG. 13, the delivery sheath 316 of the device catheter 314can then be retracted to expose the anchors 310 of the device 300.Exposing the anchors 310 allows the anchors 310 to self-expand from theunfolded, radially compressed delivery configuration (shown in FIG. 10)to a folded, radially expanded configuration (shown in FIGS. 9, 11-12).With the anchors exposed, the shaft 318 of the delivery catheter 314 canbe rotated to orient the anchors 310 to a desired position for capturingthe leaflets 326.

As shown in FIG. 14, the anchors can be positioned behind theventricular portions of the leaflets 326 (e.g., desirably at the A2 andP2 positions). FIG. 15 shows that the delivery sheath 316 of the devicecatheter 314 can then be further retracted to expose the spacer body 304of the device 300, allowing the body 304 to self-expand to a radiallyexpanded configuration. In the expanded configuration, the body 300 ofdevice 300 contacts the atrial portions of the leaflets 326. Thus, theleaflets are secured between the anchors 310 and the body 304 of thedevice 300 by clamping the leaflets 326 between the anchors 310 and thebody 304 with the compressive forces applied by the anchors 310 and thebody 304 to the ventricular and atrial portions of the leaflets 326,respectively.

With the leaflets 326 secured between the anchors and the body, theshaft 318 of the device catheter 314 can be disconnected from theproximal end 308 of the device 300 (as shown in FIG. 16), and the devicecatheter 312 can be retracted into the outer catheter. The outercatheter and the guide wire 320 can then each be retracted and removedfrom the patient, as shown in FIG. 17. The device 300 can have an innerfoam core such that when the guide wire 320 is retracted through thedevice, the inner foam of the device seals the guide wire lumen toprevent blood flow through the device 300.

FIG. 18 shows an exemplary implantable prosthetic device 400 having anoverall configuration similar to that of device 300, including aventricular end portion 402, a spacer body 404, a shaft 406, and aproximal end portion 408. The ventricular end portion 402 comprises oneor more anchors 410 (two in the illustrated embodiment) extending fromthe ventricular end portion 402. The spacer body 404 comprises aplurality of frictional elements 416. For example, each of the pluralityof frictional elements 416 can comprises outwardly projections that canpress into and/or penetrate leaflet tissue to minimize leaflet motionbetween the anchors 410 and the body 404 and improve tissue ingrowth, asshown in FIG. 18. In another embodiment, the frictional elements cancomprise a textured surface formed in and/or applied to theblood-impervious covering of body 404.

The device 400 can also include one or more wires, sutures, tethers, orchords 412 (two in the illustrated embodiment) and a clip 414. The wires412 can comprise distal ends 418, proximal ends 420 and intermediateportions 422 positioned between the distal ends 418 and the proximalends 420. The distal end 418 of each of the wires 412 can be fixedlysecured to a respective anchor 410 of the device 400 by an adhesive,welding, fastener, etc. The proximal ends 420 of the wires 412 can eachbe releasably connected to additional wires (not shown) of a deliveryapparatus, respectively. The intermediate portions 422 of the wires 412each extend co-axially through the shaft 406, the body 404, and the clip414 of the device 400. The clip 414 can be fixedly secured to theproximal end 408 of the device 400 by adhesive, welding, fastener, etc.The clip 414 can also be adjustably-connected to the wires 412 andreleasably connected to a delivery apparatus (not shown).

The device 400 can be delivered percutaneously to a native heart valve(e.g., the mitral valve) using a delivery apparatus and proceduresimilar to those described above with respect to device 300 (see FIGS.13-17).

Due to the flexible nature of the device 400 and the addition of thewires 412 and clip 414, the clamping force on the leaflets can befurther increased by applying a tensile force to the proximal ends 420of the wires 412 (pulling the wires proximally in the direction of arrow424) while maintaining the axial position of the clip 414. This actionpulls the anchors 410 towards the body 404, thereby decreasing the spacebetween the anchors 410 and the body 404. The tensile force can beapplied to the proximal ends of the wires 412, for example, by pullingon additional wires of a delivery apparatus which can be releasablyconnected to the proximal end of each wire 412 of the device 400. Theclip 414 can be configured to retain the axial position of the wires 412when the tensile force is removed. For example, the clip 414 can beconfigured to allow axial movement of the wires 412 in the proximaldirection 424 but prevent axial movement of the wires 412 in theopposite direction when the tensile force is removed. In anotherembodiment, for example, the wires 412 can comprise teeth and the clip414 can comprise pawls, forming a ratchet which only allows the wires412 to move proximally with respect the clip 414.

FIG. 19 shows an exemplary heat forming sequence used to manufacture thedevices 300, 400. The devices 300, 400 can be formed by placing atubular piece of a braided self-expanding material over a mandrel(s) andthen annealing the material in the configurations shown in FIG. 19a-h .When formed in this sequence, the devices expand in the same sequencewhen exposed from a delivery sheath.

FIGS. 20-24 show an exemplary embodiment of an implantable prostheticdevice 500, which is similar to device 300, according to anotherembodiment. The prosthetic device 500 in the illustrated embodimentcomprises a ventricular portion 502, a spacer body 504, and an innershaft 506 on which the ventricular portion 502 and the spacer body 504are mounted.

As best shown in FIG. 22 (which shows the device in a compresseddelivery state), the ventricular portion 502 includes a distal end 508and a proximal end 510 (shown in FIG. 22) each disposed on the shaft506, and one or more ventricular anchors 512 (one in the illustratedembodiment) extending from the distal end portion 508. In someembodiments (shown in FIG. 21b ), the ventricular portion 502 can alsoinclude a one or more openings 522 located near the distal end 508 ofthe ventricular portion 502. The device 500 as shown in FIG. 21b has twoopenings 522, however, because the openings are the same shape and sizeand located opposite each other (circumferentially) there only appearsto be one opening. Such openings 522 effectively create multipleventricular anchors 512 (two in FIG. 21b ) when the ventricular portion502 folds into a radially expanded functional state, as furtherdescribed below. In alternative embodiments, the ventricular portion 502of the device 500 can, for example, have three openings 520, effectivelycreating three anchors for use in a heart valve comprising three nativeleaflets (e.g., the tricuspid valve).

A distal sleeve 514 can be inserted over the distal end 508 of theventricular portion 502 and mounted to the distal end of the shaft 506to radially compress the distal end 508 against the inner shaft 506 andto retain the ventricular portion 502 on the shaft 506. The proximal end510 of the ventricular portion 502 is attached to the distal end of anintermediate sleeve 516 (shown in FIG. 22), which is disposed on theshaft 506. The spacer body 504 is attached at its distal end to theproximal end of the intermediate sleeve 516 and at its proximal end tothe distal end of a proximal sleeve or shaft 518, which extendsco-axially over a proximal end of the inner shaft 506. Thus, the innershaft 506 extends co-axially through the proximal sleeve 518, the spacerbody 504, the intermediate sleeve 516, the ventricular portion 502, andthe end cap 514. The inner shaft 506 is axially moveable relative to theproximal sleeve 518 and the intermediate sleeve 516 to effect expansionof the device during delivery of the device 500, as further describebelow.

As shown, the ventricular portion 502 and the spacer body 504 of device500 can be formed from a single, unitary piece of material. When theventricular portion 502 and the spacer body 504 of device 500 are formedfrom a single piece of material, the intermediate sleeve 516 can beoptional. In alternative embodiments, however, the ventricular portion502 and the body 504 of device 500 can be formed from separate pieces ofmaterial. When the ventricular portion 502 and the spacer body 504 ofdevice 500 are formed from separate pieces of material, the proximal end510 of ventricular portion 502 and the distal end of the spacer body 504can each be connected to intermediate sleeve 516 by adhesive, welding,fastener, etc. Alternatively, the proximal end 510 of ventricularportion 502 and the distal end of the spacer body 504 can each beconnected directly together by adhesive, welding, fastener, etc. withoutthe use of intermediate sleeve 516.

In the illustrated embodiment, the spacer body 504 of device 500 has agenerally spherical shape, although the body 504 can have various othershapes in other embodiments (e.g., cylindrical, conical, etc.). The body504 of device 500 can also be configured to address central and/oreccentric jet mitral regurgitation. It should be noted that any of thedevices disclosed herein can comprise spacer bodies of various shapesand can be configured to address central and/or eccentric jet mitralregurgitation.

As shown in FIG. 20, the ventricular portion 502 and the spacer body 504of device 500 can formed from a self-expandable braided material. Thebraided material can be formed from a metallic thread, such as Nitinol.Similar to devices described above, the braided material of the device500 can be covered with a blood impervious cover or coated with aflexible sealant material to prevent blood flow through the device 500.FIG. 20 shows the device 500 in a radially expanded functional state.The device 500 can be radially compressed to a delivery configuration bymoving the distal end 508 of the ventricular portion away from theproximal end of the spacer body 504, which effectively elongates orstretches the device into a radially compressed tubular configuration(as shown in FIGS. 21 and 22). With the device 500 in the deliveryconfiguration, device 500 can be delivered percutaneously to a nativeheart valve (e.g., the mitral valve) similar to the delivery apparatus312 described above.

With a sheath 520 of the delivery apparatus in the left ventricle, theventricular portion 502 of the device 500 can be advanced from thesheath of the delivery catheter by axially advancing the inner shaft 506and the proximal sleeve 518 of the device 500 such that the ventricularportion 502 extends into the left ventricle from within the deliverysheath. The ventricular portion can then be folded and expanded byretracting the inner shaft 506 axially relative to the proximal sleeve518 and the delivery sheath 520, as shown in FIG. 23. In thisconfiguration, the anchors can be placed against the ventricularportions of the native leaflets.

The leaflets can then be secured by retracting the proximal sleeve 518axially relative to the inner shaft 506 and the delivery sheath 520,which causes the body 504 to expand radially, as shown in FIG. 24. Withthis action, the leaflets are captured between anchors 512 and thespacer body 504 of the device 300, which brings them closer togetheraround the spacer body 504. By so doing, the device 500 decreases theoverall area of the mitral valve orifice and divides the mitral valveorifice into two orifices during diastole. Thus, the area through whichmitral regurgitation can occur is reduced, leaflet coaptation can beinitiated at the location of the body 504, and the leaflets can fullycoapt more easily, thereby preventing or minimizing mitralregurgitation. With the leaflets captured and the device 500 expanded toits functional state, the proximal sleeve 518 can be disconnected fromthe proximal end of the body 504 and retracted into the delivery sheath520, both of which can then be retracted from the patient's body.

Although devices 300, 400, 500 show one or two anchors, in someembodiments, devices 300, 400, 500 can, for example, have three anchorsand can be delivered to a native heart valve with three leaflets (e.g.,the tricuspid valve). It should be noted that any of the embodimentsdisclosed herein can comprise one or more anchors.

FIGS. 25-34 show an exemplary embodiment of an implantable prostheticdevice 600, which is similar to device 500, according to anotherembodiment. The prosthetic device 600 in the illustrated embodimentcomprises an inner shaft 602, a distal end cap 604, a braided portion606, and an outer shaft 608. The braided portion 606 includes one ormore anchor portions 610 (two in the illustrated embodiment) and a bodyportion 612. The inner shaft 602 extends co-axially through the outershaft 608, the body 612 of the braided portion 606, and the end cap 604.The end cap 604 can be fixedly secured to the distal end of the innershaft 602 to prevent axially movement of the end cap 604 along the innershaft 602.

Each of the anchors 610 of the braided portion 606 comprise lower legportions 614, upper leg portions 616, and joints 618 positioned betweeneach lower leg 614 and upper leg 616, respectively, defined by the foldsin the leg portions when deployed. The distal ends of the lower legs 614can be fixedly secured into the end cap 604 to retain them against, andprevent axial movement relative to, the inner shaft 602. The proximalends of the upper legs 616 can be attached to the distal end of body 612of the braided portion 606. The proximal end of the body 612 of thebraided portion 606 can be releasably attached to the distal end of theouter shaft 608 by inserting the proximal end of the body 612 into thedistal end of the outer shaft 608 or by a separate retaining device thatcouples the proximal end of the body to the end of the outer shaft 608.The outer shaft 608, and thus the body 612, can be adjustably moveableaxially relative to the inner shaft 602 to effect the configuration ofthe device 600 during the device placement procedure, as furtherdescribed below.

The end cap 604 can be fixedly secured to the distal end of the innershaft 602, for example, by adhesive, welding, fasteners, etc.Alternatively, the end cap 604 can be fixedly secured to the distal endof the inner shaft 602, for example, by forming the end cap 604 and theinner shaft 602 from a single, unitary piece of material.

In some embodiments, the anchors 610 can be independently moveablerelative to each other. For example, the device 600 can have a pluralityof inner shafts 602 that are independently movable relative to eachother, and each of the anchors 610 can each be coupled to a respectiveinner shaft 602.

The outer shaft 608 can be adjustably moveable axially relative to theinner shaft 602, such as by pushing or retracting the outer shaft 608axially relative to the inner shaft, or vice versa. In an alternativeembodiment, for example, the inner shaft 602 can comprise externalthreads and the outer shaft 608 can comprise internal threads thatengage the external threads of the inner shaft 602. Thus, rotation ofthe outer shaft 608 relative to the inner shaft is effective to move theouter shaft 608, and thus the spacer body 612, along the length of theinner shaft 602.

The braided portion 606 of the device 600 can be formed from a single,unitary piece of braided material. The braided material can be formedfrom a self-expandable metallic thread, such as Nitinol. For example,FIG. 26 shows the braided portion 606 of the device 600 formed from asingle piece of braided material with the anchor portions 610 extendedin an unfolded configuration and the body 612 slightly expanded. In analternative embodiment, the anchors 610 and the body 612 can be formedfrom separate pieces of braided material, in which case the anchors 610and the body 612 can be connected by attaching the proximal ends of theupper legs 616 of the anchors 610 and the distal portion of the body 612to a connecting sleeve 620 (shown in FIG. 25). When formed from aself-expandable material, the braided portion 606 can be radiallycompressed to a delivery configuration and can be retained in thedelivery configuration by placing the device 600 in the sheath of adelivery apparatus, as shown in FIG. 27. When deployed from the deliverysheath, the braided portion 606 of the device 600 can self-expand to afunctional configuration, as further described below.

The device 600 can be delivered percutaneously to a native heart valve(e.g., the mitral valve) with a delivery apparatus. FIGS. 27-34 show thedevice 600 being deployed from a delivery apparatus. The deliveryapparatus can comprise an outer catheter (e.g., outer catheter 520 ofFIG. 23) and an implant catheter 622. The implant catheter 622 cancomprises a delivery sheath 624, an inner shaft (not shown), and anouter shaft 608 (shown in FIG. 25). The inner shaft and the outer shaft608 extend co-axially through the delivery sheath 624 of the implantcatheter 622, and the inner shaft extends co-axially through the outershaft 608 of the implant catheter 622.

Prior to insertion into the patient's body, the proximal end of theinner shaft 602 of the prosthetic device 600 can each be connected tothe distal end of inner shaft (not shown) of the implant catheter 622,the outer shaft 608 can be coupled to the proximal end of the spacerbody 612, and then the prosthetic device 600 can be loaded into thedelivery sheath 624. The delivery apparatus can then be advanced in apatient's heart (not shown) via, for example, the transseptal techniquedescribed above (see FIGS. 6-8), FIG. 27 shows the sheath 624 of theimplant catheter 622 restraining the prosthetic device 600 in thedelivery configuration, In this configuration, the implant catheter canbe advanced across the native mitral valve leaflets of a heart (notshown) until the distal end of the inner shaft 602 and the end cap 604of the device 600 are in the left ventricle (similar to the positioningof shown in FIG. 6).

As shown in FIG. 28, the anchors 610 of the braided portion 606 of thedevice 600 can be exposed by advancing the inner shaft and the outershaft 608 of the implant catheter 622 distally relative to the deliverysheath 624 and/or retracting the delivery sheath 624 relative to theinner shaft and the outer shaft 608, thus forcing the anchors 610 out ofthe sheath 624. Once exposed from the sheath 624, the joints 618 of theanchors 610 can expand radially away from the inner shaft 602, as shownin FIG. 29. The anchors 610 can be folded by retracting the inner shaftof the implant catheter 622 (which is connected to the inner shaft 602of the implant 600) relative to the outer shaft 608 and the sheath 624,which in turn causes the inner shaft 602 to retract, causing the anchors610 to bend at the joints and upper legs 616 to fold inwardly towardsthe inner shaft 602, as shown in FIGS. 30 and 31. In this configuration,the anchors 610 can be positioned behind the ventricular portions of theleaflets (e.g., desirably at the A2 and P2 positions).

The body 612 of the braided portion 606 of the device 600 can be exposedby further retracting the delivery sheath 624 relative to the inner andouter shafts of the implant catheter (as shown in FIG. 32) and/oradvancing the shafts distally relative to the sheath 624, which allowsthe body 612 to expand radially (as shown in FIG. 33) and therebycapture the leaflets between the upper legs 616 of the anchors 610 andthe spacer body 612. The leaflets can then be secured between the upperlegs 616 of the anchors 610 and the spacer body 612 of the braidedportion by advancing the outer shaft 608 of the implant catheter 622relative to the inner shaft 602 and the delivery sheath 624 of theimplant catheter 622 such that the spacer body 612 moves axially towarddistal end of the inner shaft 602 until it abuts the end cap 604, atwhich point further advancing the outer shaft compresses the endportions of the spacer body 612 between the end caps 604 and the outershaft 608.

Compressing the ends of the spacer body 612 foreshortens the spacer body612 axially and expands it radially, which forces the spacer body 612radially outward against the leaflets, as shown in FIG. 34. Thus, thedevice 600 can be secured by clamping the leaflets between the upperlegs 616 of the anchors 610 of the braided portion 606 and the spacerbody 612 of the braided portion 606. Thereafter, the inner and outershafts of the implant catheter 622 can be released from the device 600and the delivery apparatus can be removed from the patient.

FIG. 35 show an exemplary embodiment of an implantable prosthetic device900 similar to device 600, including a braided portion 906, according toanother embodiment. The braided portion 906 of the device 900 includesone or more anchors 910 (two are shown in the illustrated embodiment)and a spacer body 912. As shown, the anchors 910 of the braided portion906 of the device 600 can be formed from a braided piece of materialwhich is separate from the braided piece of material forming the spacerbody 912. The anchors 910 each include a lower leg 914 and an upper leg916. Each upper leg 916 can be inserted into and attached to an end cap904 which is disposed on the distal end of an inner shaft (not shown) ofthe device 900. Each lower leg 914 can be connected to the other lowerleg 914. For example, in some embodiments, the lower legs 914 of theanchors 910 can be formed from a single continuous piece of braidedmaterial, shown in FIG. 35 as the laterally extending sectionperpendicular to the spacer body 912. In some embodiments (where eachanchor 910 is formed from a separate piece of braided material), thelower legs 914 can, for example, be connected by inserting the ends ofthe lower legs 914 into a coupler or sleeve which compressively securesthe ends of the lower leg 914 within the coupler.

FIG. 36 shows another exemplary embodiment of an implantable prostheticdevice 700. The device 700 comprises one or more ventricular anchors 702(two in the illustrated embodiment), a spacer body 704, one or moreanchor actuation lines 706 (FIG. 36 shows two), and a pull wire 708. Theactuation lines 706 and the pull wire 708 extend co-axially through thebody 704.

The anchors 702 can comprise a plurality of leaflet retention elements712. For example, FIG. 36 shows that the retention elements 712 cancomprises outwardly extending projections or barbs that can press intoand/or penetrate leaflet tissue to secure the anchors 702 to theleaflets. In another embodiment, the retention elements can comprise atextured surface formed in and/or applied to the anchors 702 of thedevice 700.

The spacer body 704 can comprise a collar 710 positioned toward theventricular end of the body 704 of the device 700 and a braided portion714. Although the braided portion has a generally cylindrical shape whenin the expanded configuration shown in the illustrated embodiment, thebraided portion can have various other shapes in other alternativeembodiments. For example, the braided portion can expand to a generallyspherical shape (similar to the body 504 in FIG. 20).

The braided portion 714 can be fixedly secured to the collar 710 such asby adhesive, welding, fasteners, etc. The anchors 702 can also befixedly secured to the collar 710. In some embodiments, the anchors canbe fixedly secured to the collar 710, for example, by welding,fasteners, or an adhesive. In alternative embodiments, the anchors 702can be fixedly secured to the collar 710, for example, by forming theanchors 702 and the collar 710 from a single piece of material (e.g.,laser cutting a metal tube).

The anchor actuation lines 706 can be wires or sutures formed fromvarious materials such as nylon, polyester, PVDF, polypropylene,stainless steel, etc. Each line 706 comprises a first end 716 which isfixedly secured or coupled to a respective free end of an anchor 702, asecond end (not shown) which is fixedly secured or coupled to the distalend of the pull wire, and an intermediate portion positioned between thefirst end 716 and the second end. In the illustrated embodiment, thelines 706, beginning at the first ends 716 and moving toward the secondends, each extend outwardly away from the free end of the anchors 702,downwardly toward the collar 710 of the body 704, co-axially through thecollar 710, and co-axially into the braided portion 714 of the body 704,and are secured to the pull wire 708 within the braided portion 714 ofthe body 704.

The anchors 702 can be formed from a self-expandable material, such asNitinol. The braided portion 714 of the body 704 can also be formed froma self-expandable material, such as braided Nitinol. When formed from aself-expandable material, the anchors 702 and the braided portion 714 ofthe body 704 can be radially compressed to a delivery configuration andcan be retained in the delivery configuration by placing the device 700in the sheath of a delivery apparatus.

When deployed from the sheath, the anchors 702 and the braided portion714 can radially expand, creating gaps between the anchors 702 and thebraided portion 714 of the body 704 wherein the native leaflets 718 of aheart valve can be placed, as shown in FIG. 36. The leaflets 718 canthen be secured between the anchors 702 and the braided portion 714 byapplying tension to the pull wire 708 and thereby the lines 706, causingthe free end of the anchors 702 to bow or bend outwardly and the portionof the anchors 702 disposed between the free end and the fixed end ofthe anchors 702 (i.e., the middle portion) to buckle inwardly, whichthrees the retention elements into the leaflets 718. With the retentionelements 712 inserted into the leaflets 718, the device 700 can maintainits position relative to the leaflets during diastole and systole.

FIGS. 37-47 show another exemplary embodiment of an implantableprosthetic device 800 and its components. In the illustrated embodiment,the device 800 comprises one or more ventricular anchors 802 (two in theillustrated embodiment), a spacer body 804, an interior shaft portion806. The interior shaft portion 806 extends co-axially through thespacer body 804. The anchors 802 press radially inward toward theinterior shaft 806 to create a clamping force between the anchors 802and the spacer body 804, as further described below.

FIGS. 41-44 show the anchors 802 and the spacer body 804 of the device800 in the expanded functional state. FIG. 45 shows the anchors 802 andthe spacer body 804 of the device 800 in the crimped or compresseddelivery state. FIG. 46 shows anchors 802 of the device 800 in thefunctional state.

FIG. 37 shows that the spacer body 804 can comprise a metal framecomprising a distal, first annular collar 808 disposed around the shaft806 and positioned towards the ventricular end of the spacer body 804 ofthe device 800, a proximal, second annular collar 810 disposed aroundthe shaft 806 and positioned towards the atrial end of the spacer body804 of the device 800, and a plurality of interconnected struts 812extending between the first and second collars 808, 810. The struts 812can, for example, be fixedly secured to the collars 808, 810 by formingthe struts 812 and the collars 808, 810 from a single, unitary piece ofmaterial (e.g., laser cutting a metal tube). In other embodiments, thestruts 812 can, for example, be fixedly secured to the collars 808, 810by an adhesive, welding, fasteners, etc. Although not shown in FIGS.37-47, the frame can be covered with a blood-impervious cover (e.g.,fabric) or coated with a flexible sealant (e.g., ePTFE).

FIG. 37 also shows that the anchors 802 of device 800 can each comprisea flexible tube portion 814. The tubes 814 can be formed from alloytubing such as, for example, Nitinol, stainless steel, cobalt chromium,etc. The proximal ends of the tubes 814 can be, for example, fixedlysecured or coupled to the distal collar 808, such as by an adhesive,welding, fasteners, etc. The tubes 814 can also be configured to allowthe tubes 814 to bend more easily in a desired direction and/or with atighter bend radius without plastically deforming (e.g., kinking). Forexample, as shown, a portion of the circumference of the tubes 814 canbe formed (e.g., by laser cutting) such that a section of the tubescomprises a plurality of axially spaced, circumferential ribs 830 on afirst, cut side of the tubes and a solid portion or spine 832 on asecond, non-cut side opposite to the cut side, relative to thecircumference the tube. By cutting the tubes on one side, the tubes 814can bend more easily in the direction of the side of the tube with theribs 830, relative to the side with the spine 832.

The tubes 814 can also be cut asymmetrically with respect to thelongitudinal axis of the tubes 814 such that the ribs 830 are orientedon different sides of the tubes 814 for different axial sections. Forexample, as shown, the tubes 814 each comprise a first cut section 838,located near the proximal ends of the tubes 814 (the ends fixedlysecured to the distal collar 808), wherein the ribs 830 face outwardly(i.e., away from each other) when the tubes are extended or straightenedin the crimped or delivery configuration (shown in FIG. 45) and a secondcut section 840 located more distally relative to the first cut section838, wherein the ribs 830 face inwardly (i.e., towards each other) whenthe tubes are extended or straightened in the crimped or deliveryconfiguration. The first cut section 838 and the second cut section 840can, for example, be separated by an un-cut transition section 834 (FIG.37).

In some embodiments, the different axial sections can be form from asingle piece of material. In other embodiments, the different axialsections can be formed from separate pieces of material fixedly securedor coupled together. Also, the ribs of the different axially sectionscan be different sizes to allow the respective axial sections to bendmore or less tightly. For example, as shown, in the proximal sections838, the ribs 830 of the tubes 814 can be relatively thinner (i.e., moreof the tubing has been removed during the cutting process) than the ribs830 of the second more distal sections 840, allowing the first sections838 to have a smaller bend radius relative to the second sections 840.Thus, by cutting the tubes 814 and orienting the ribs 830, the mannerand sequence that the tubes bend/buckle and extend/straighten can becontrolled, as further described below.

FIG. 38 shows the device 800 with the tubes 814 of the anchors 802removed, thus exposing pull wires 816 (two are shown) of the anchors802. The pull wires 816 can each extend co-axially within a respectivetube 814 of an anchor 802 and can be fixedly secured to the shaftportion 806 at a first, proximal end 842 (FIG. 40) of the pull wires816, and fixedly secured to the interior portion of the tubes 814 nearthe distal end of the tubes 814 at a second, distal end 844 of the pullwires 816, as further described below. The pull wires 816 can, forexample, be used to move the anchors 802 from the crimped delivery state(shown in FIG. 45) to the expanded functional state (shown in FIG. 37)and/or secure native leaflets between the anchors 802 and the spacerbody 804, as further described below.

As best shown in FIGS. 39-40, the shaft assembly 806 of the device 800in the illustrated configuration includes a threaded bolt 818, a washer820, and a shaft or shim support sleeve 822. The threaded portion of thebolt 818 extends co-axially through the washer 820 and the sleeve 822 ofthe shaft 806. The bottom (distal) surface of the head portion of thebolt 818 abuts the top (proximal) surface of the washer 820. The bottom(distal) surface of the washer 820 abuts the proximal end of the sleeve822 of the shaft assembly 806 and the proximal end of the proximalcollar 810 of the spacer body 804. The sleeve 822 can be fixedly securedto the inner surfaces of the collars 808, 810 of the spacer body 804 atrespective ends of the sleeve 822.

The shaft 806 assembly can also include a nut 824 and nut support rails826 (two are shown), as best shown in FIG. 40. The nut 824 is disposedon the threaded portion of the bolt 818 and within the sleeve 822. Thenut 824 can comprise internal threads, which correspond to the threadedbolt 818. The nut 818 can also comprise a plurality of axially extendingexternal notches or grooves 828 through which the rails 826 and the pullwires 816 extend preventing the nut 818 from rotating relative to thebolt 818, thereby producing axial movement of the nut upon rotation ofthe bolt. The rails 826 can be fixedly secured to the sleeve 822,preventing the rails 826 and, thus, the nut 824 from rotating relativeto the spacer body 804.

By rotating the bolt 818, the nut 824 can slide axially along the rails826 and moves axially, either proximally or distally (depending on thedirection of rotation), along the threaded portion of the bolt 818without rotating. The proximal ends of the pull wires 816 of the anchors802 can be fixedly secured to the nut 824. Thus, rotating the bolt 818moves the nut 824 and thus the pull wires 816 proximally or distally,depending on the direction of rotation. Rotating the bolt 818 such thatthe wires 816 move proximally (in the direction of arrow 846) applies acompressive force to the tubes 814, causing the tubes 814 of the anchors802 bend or buckle into the functional state from the straightened,delivery configuration.

As shown, the pull wires 816 can be sufficiently rigid such that thepull wires 816 can apply a pushing force. Thus, rotating the bolt 818such that the pull wires 816 move distally applies a tensile force tothe tubes 814, causing the tubes to extend and/or straighten to adelivery configuration (shown in FIG. 45). In an alternative embodiment,the tubes 814 can be formed from a shape memory material (e.g., Nitinol)which have been pre-formed in the straightened, delivery configuration.Thus, rotating the bolt 818 such that the pull wires 816 move distallyremoves the compressive force from the tubes 814, allowing the tubes 814to straighten to the delivery configuration.

The device 800 can be delivered percutaneously to a native heart valve(e.g., the mitral valve with a delivery apparatus (not shown), forexample, using the transseptal technique described for the prostheticdevice 200 and the delivery apparatus 202 (shown in FIGS. 6-8). Thedevice 800 and associated delivery apparatus can be advanced across thenative mitral valve leaflets 836 until the anchors 802 of the device 800are in the left ventricle (similar to the configuration shown in FIG.6). The device 800 can be advanced from the delivery sheath (not shown,but similar to sheath 216) to expose the anchors 802.

In some embodiments, the anchors 802 can be self-expandable (e.g.,formed from a shape-memory material, such as Nitinol) such that theanchors can transition from the delivery configuration (best shown inFIG. 45) to a leaflet capture configuration (best shown in FIG. 47) whendeployed from the delivery sheath in a manner similar to device 300 (asshown in FIGS. 13 and 14). When formed from a self-expandable material,the shaft 806 and the pull wires 816 can be used to secure the leaflets,as further described below. In some embodiments, the anchors 802 can beplastically deformable (e.g., formed from stainless steel). When formedfrom a plastically deformable material, the anchors 802 can be expandedfrom the delivery configuration to the leaflet capture configuration byrotating the bolt 818 using a torque shaft (not shown, but similar totorque shaft 220), causing the anchors 802 to bend, as best shown inFIG. 46 and described in detail above.

The spacer body 804 can then be deployed by further retracting thedelivery sheath, allowing the spacer body to radially expand and capturethe native leaflets 836 between the anchors 802 and the spacer body 804,as shown in FIG. 47. The leaflets 836 can then be tightly securedbetween the anchors 802 and the spacer body 804 by rotating the torqueshaft and the bolt 818, causing the nut 824 and the wires 816 to moveproximally along the threaded shaft portion 806. Movement of the wiresis effective to cause the tubes 814 to bend and further urge the anchors802 against the leaflets 836. Thus, the prosthetic device 800 can besecured to the leaflets 836 by clamping the leaflets between the anchors802 and the spacer body 804, as shown in FIG. 47. Thereafter, thedelivery device can be removed from the patient's body.

With the device 800 secured to both of the leaflets 836, it brings themcloser together around the spacer body 804. By so doing, the device 800decreases the overall area of the mitral valve orifice and divides themitral valve orifice into two orifices during diastole. Thus, the areathrough which mitral regurgitation can occur is reduced, leafletcoaptation can be initiated at the location of the body 804, and theleaflets can fully coapt more easily, thereby preventing or minimizingmitral regurgitation.

FIGS. 48-52 show another exemplary embodiment of an implantableprosthetic device 1000, similar to device 800. In the illustratedembodiment, the device 1000 comprises one or more ventricular anchors1002 (two in the illustrated embodiment), a spacer body 1004, aninterior shaft assembly (not shown, similar to the shaft assembly 806 ofthe device 800). The interior shaft assembly extends co-axially throughthe body 1004. The anchors 1002 press radially inward toward theinterior shaft to create a clamping force between the anchors 1002 andthe spacer body 1004, as further described below.

As best shown in FIG. 49, the spacer body 1004 can comprise a metalframe comprising a distal, first annular collar 1008 disposed around theshaft assembly (not shown) and positioned towards the ventricular end ofthe spacer body 1004, a proximal, second annular collar 1010 disposedaround the shaft assembly and positioned towards the atrial end of thespacer body 1004 of the device 1000, and a plurality of interconnectedstruts 1012 extending between the first and second collars 1008, 1010.In some embodiments, the struts 1012 can, for example, be fixedlysecured to the collars 1008, 1010 by forming the struts 1012 and thecollars 1008, 1010 from a single, unitary piece of material (e.g., lasercutting a metal tube). In other embodiments, the struts 1012 can, forexample, be fixedly secured to the collars 1008, 1010 by an adhesive,welding, fasteners, etc. Although not shown in FIGS. 48-52, the spacerbody 1004 can be covered with a blood-impervious cover (e.g., fabric) orcoated with a flexible sealant (e.g., ePTFE).

As shown, the anchors 1002 of device 1000 can each comprise a flexibletube portion 1014. The tubes 1014 can be formed from alloy tubing suchas, for example, Nitinol, stainless steel, cobalt chromium, etc. Theproximal ends 1020 (FIG. 52) of the tubes 1014 can be, for example,fixedly secured or coupled to the distal collar 1008, such as by anadhesive, welding, fasteners, etc.

The tubes 1014 can also be configured to allow the tubes 1014 to bendmore easily in a desired direction and/or with a tighter bend radiuswithout plastically deforming (e.g., kinking). For example, as shown, aportion of the circumference of the tubes 1014 can be framed (such as bylaser cutting) such that a section of the tubes comprises a plurality ofribs 1016 on a first, cut side of the tubes and a solid portion or spine1018 on a second, non-cut side opposite to the cut side, relative to thecircumference the tube. By cutting the tubes on one side, the tubes 1014can bend more easily in the direction of the side of the tube with theribs 1016, relative to the side with the spine 1018. The tubes 1014 canalso be cut asymmetrically with respect to the longitudinal axis of thetubes 1014 such that the ribs 1016 are oriented on different sides ofthe tubes 1014 for different axial sections, as best shown in FIG. 52.Thus, by cutting the tubes 1014 and orienting the ribs 1016, the mannerand sequence that the tubes 1014 bend/buckle and extend/straighten canbe controlled.

Although not shown, the interior shaft assembly of device 1000 can besimilar to shaft portion 806 of device 800, including comprisingsubstantially the same components. Also, the anchors 1002 can compriseanchor pull wires (not shown, but similar to the wires 816), fixedlysecured to a nut (not shown) of the shaft at a first, proximal end ofthe wires and fixedly secured to the distal ends of tubes 1014 at asecond, distal end of the wires, similar to the wires 816. Thus, thedevice 1000 can function substantially similarly to the device 800. Theanchors 10 of device 1000 can, however, contact the native leaflets (notshown) laterally.

With respect to the device 1000, the term “lateral” means generallyperpendicular to the longitudinal axis of the prosthetic device 1000extending through the distal and proximal collars 1008, 1010. Forexample, FIG. 49 shows the anchors extending laterally across the spacerbody 1004, with the longitudinal axis extending coaxially through thecollars 1008, 1010. Thus, in this manner, each anchor 1002 can extendlateral across and in contact with the ventricular side of a respectivenative leaflet.

It should be noted that although the anchors 802, 1002 of the respectivedevices 800, 1000 can be simultaneously actuated (e.g., moved from thedelivery configuration to the functional configuration and/or securedagainst native leaflets, etc.), as described above, in some embodimentseach individual anchor can be separately actuated. For example, one ofthe anchors 802, 1002 can be moved from the delivery configuration tothe functional configuration and can be secured to a native leaflet, andthen, subsequently, another anchor 802, 1002 can be moved from thedelivery configuration to the functional configuration and can besecured to a native leaflet.

In order to allow the anchors to be separately actuated, the shaftassemblies (similar to shaft assembly 806) can, for example, includemultiple bolts and nuts (similar to bolt 818 and nut 824), with eachbolt and nut corresponding to a separate pull wire of a respectiveanchor. By having separate bolts and nuts for each pull wire, eachanchor can be actuated by rotating the bolt corresponding to the anchor,causing the nut to move axially along the threaded portion of the boltand the anchor to either fold/bend or to extend/straighten depending onthe direction of rotation of the bolt.

FIGS. 53-58 show another exemplary embodiment of an implantableprosthetic device 1100. In the illustrated embodiment, the device 1100comprises a ventricular portion 1102, a spacer body 1104, an inner shaft1106, and an outer shaft 1108. The inner shaft 1106 extends co-axiallythrough the outer shaft 1108, and the inner and outer shafts 1106, 1108extend co-axially through the spacer body 1104. The outer shaft 1108 canbe axially moveable (proximally and distally) relative to the innershaft 1106 and the spacer body 1104. The distal direction is indicatedby arrow 1120 (FIG. 53), the proximally direction being generallyopposite the distal direction. The spacer body 1104 can be axiallymoveable (proximally and distally) relative to the inner shaft 1106 andthe outer shaft 1108.

The ventricular portion 1102 includes one or more outer anchor members1110 (two in the illustrated embodiment), one or more inner anchormembers 1112 (two in the illustrated embodiment), one or morecross-members 1114 (two in the illustrated embodiment). The outeranchors 1110 can be pivotal connected (e.g., a pin, fastener, balljoint, etc.) to the distal end of the inner shaft 1106 at first, distalends of the outer anchors 1110, forming a first pivotable joint 1116.The outer anchors 1110 extend from the first joint 1116 to second,proximal ends of the outer anchors 1110. The inner anchors 1112 can bepivotably connected to respective outer anchors 1110 at intermediateportions of the inner anchors 1112, forming second pivotable joints1118. The cross-members 1114 can be pivotably connected to the distalend of the outer shaft 1108 at first, inner ends of the cross-members1114, forming a third pivotable joint 1122. The cross-members 1114 canbe pivotably connected to respective distal ends of the inner anchors1112 at second ends (opposite to the first ends) of the cross-members1114, forming fourth pivotable joints 1124.

The cross-members 1114 can also be slidably connected to respectiveouter anchors 1110 with connecting elements 1126. As best shown in FIG.53, the connecting elements 1126 can be disposed on respective outeranchors 1110 between the pivotable joints 1116 and 1118 and disposed oncross-members 1114 between pivotable joint 1122 and pivotable joints1124. The connecting elements 1126 can be, for example, slots formed inthe outer anchors 1110 through which the cross-members 1114 extend.

The spacer body 1104 can comprise an annular metal frame (not shown, butsimilar to frame 28) covered with a blood-impervious fabric 1128. Theframe can comprise a mesh-like structure comprising a plurality ofinterconnected metal struts or can comprise a metal braid. The frame canbe formed from a self-expandable material, such as Nitinol. In otherembodiments, the frame can be formed from a plastically expandablematerial, such as stainless steel or a cobalt chromium alloy.

Due to the adjustable nature of the ventricular portion 1102 and theflexible nature of the spacer body 1104, the device 1100 can be radiallycompressed to a delivery configuration (FIG. 54) and can be retained inthe delivery configuration by placing the device in the sheath of adelivery apparatus.

As shown in FIGS. 54-58, the device 1100 can be delivered percutaneouslyto a native heart valve (e.g., the mitral valve) with a deliveryapparatus (not shown), for example, using the transseptal techniquedescribed for the prosthetic device 200 and the delivery apparatus 202(shown in FIGS. 6-8). Although not shown, the delivery apparatus cancomprise a sheath (similar to sheath 216) into which the prostheticdevice 1100 can be loaded, inner and intermediate shafts releasablyconnected to respective inner and outer shafts 1106, 1108 of the device1100, and an outer shaft releasably connected to the spacer body 1104 ofthe device 1100.

The device 1100 and the delivery apparatus can be advanced across thenative mitral valve leaflets 1130 until the ventricular portion 1102 ofthe device 1100 is in the left ventricle (as shown in FIG. 55 andsimilar to the configuration shown in FIG. 6). The ventricular portion1102 can be exposed from the delivery sheath by distally advancing theinner shaft of the delivery apparatus and thus the inner shaft 1106 ofthe device 1100 relative to the sheath of the delivery apparatus and/orby retracting the delivery sheath relative to the inner shafts.

The anchors 1102 can be expanded from the delivery configuration to theleaflet capture configuration by distally advancing the outer shaft ofthe delivery apparatus and thus the outer shaft 1108 relative to theinner shaft 1106, thus moving the joint 1122 distally (i.e., towardsjoint 1116) along the inner shaft 1106 such that the cross-members 1114extend laterally, and perpendicular to the inner shaft 1106 (as shown inFIG. 55). The cross-members 1114 force the outer anchors 1110 to expandradially relative to the inner shaft 1106 and the inner anchors 1112 toexpand or open relative to the outer anchors 1110, as shown in FIG. 55.With the anchors 1110, 1112 expanded and open, the leaflets 1130 (e.g.,desirably at the A2 and P2 positions) can be positioned within theanchors 1110, 1112 by retracting the inner shaft 1106 proximally, asshown in FIG. 56.

The leaflets 1130 can then be secured between the anchors 1110, 1112 byfurther advancing the outer shaft 1108 distally relative to the innershaft 1106, causing the joint 1122 to further move distally along theinner shaft 1106 such that the joint 1122 is distal to the joints 1124,1126. Movement of the outer shaft 1108 and the cross-members 1114 iseffective to move the distal ends of the inner anchors 1112 inwardlytowards the inner shaft 1106, causing the inner anchors 1112 to pivotabout joints 1118, forcing the proximal ends of the inner anchors 1112towards the proximal ends of the outer anchors 1110, as shown in FIG.57.

FIG. 57 also shows that the spacer body 1104 can then be deployed byretracting the delivery sheath. When formed from a self-expandablematerial, the frame can self-expand to its functional size (FIGS.57-58). When formed from a plastically expandable material, theprosthetic device can be crimped onto a delivery apparatus and radiallyexpanded to its functional size by an inflatable balloon or anequivalent expansion mechanism. The spacer body 1104 can then bepositioned by advancing the outer shaft of the delivery apparatus andthus the spacer body 1104 relative to the inner and outer shafts 1106,1108 of the device 1100, as shown in FIG. 58. Although as shown, thespacer body 1104 is only partially expanded, the spacer body 1104 can befurther expanded such that the leaflets contact the spacer body 1104.The shafts of the delivery apparatus can then be released from thedevice 1100 and retracted into the sheath of the delivery apparatus.Thereafter, the delivery apparatus can be removed from the patient'sbody.

In some embodiments, as shown, the cross-members 1114 of the device 1100can each be connected to the same outer shaft 1108, thus allowing bothanchors to be simultaneously actuated. This configuration, for example,provides a device that is simple to use because there are relatively fewsteps for physician to perform to implant the device. This can, forexample, help to reduce the complexity and/or the time needed to performthe placement procedure.

In some embodiments, the cross-members 1114 of the device 1100 can eachbe connected to a separate outer shaft, thus allowing the anchors to beindividually actuated. This configuration can, for example, allow aphysician to capture the native leaflet more easily because thephysician can capture one side at a time. This can, for example, behelpful due to the dynamic nature of the leaflets during the diastolicand systolic cycles of a heart. Also, in some embodiments, the spacerbody 1104 can be fixed to the outer shaft 1108, allowing the spacer body1104 and the ventricular portion 1102 to be positioned simultaneously,which can, for example, advantageously reduce the time needed to performthe placement procedure.

FIGS. 59-61 show another exemplary embodiment of an implantableprosthetic device 1200, similar to device 1100. In the illustratedembodiment, the device 1200 comprises at least one anchor 1202 (one isshown for purposes of illustration but multiple anchors 1202 could beincluded), a spacer body (not shown, but similar to spacer body 1104), ashaft 1206, and sleeve 1208 coaxially and slidably disposed on the shaft1206. The shaft 1206 extends co-axially through the spacer body and thesleeve 1208. The spacer body is located on the shaft 1206, proximal tothe sleeve 1208.

The sleeve 1208 can be axially moveable (proximally and distally)relative to the shaft 1206. The distal direction is indicated by arrow1204 in FIG. 59, and the proximal direction is opposite the distaldirection. The spacer body can be axially moveable (proximally anddistally) relative to the shaft 1206. In some embodiments, the spacerbody can also be axially moveable relative to the sleeve 1208, allowingthe spacer body to be deployed and/or positioned separately from theanchor 1202. In some embodiments, the spacer body can be fixed orconnected to the sleeve 1208, allowing the spacer body to be deployedand/or positioned simultaneously with the anchor 1202.

As best shown in FIG. 60, the anchor 1202 can be a truss-like structurecomprising an outer member 1210, an inner member 1212, and across-member 1214. The outer member 1210 can be pivotably connected(e.g., a pin, fastener, etc.) to the distal end of the shaft 1206 at afirst, distal end of the outer member 1210, forming a first pivotablejoint 1216. The outer member 1210 extends from the first joint 1216 to asecond, proximal end of the outer member 1210. The inner member 1212 canbe pivotably connected to the outer member 1210 towards the distal endof the outer member 1210 at an intermediate portion of the inner member1212, forming a second pivotable joint 1218. The cross-member 1214 canbe pivotably connected to the sleeve 1208 at a first end of thecross-member 1214, forming a third pivotable joint 1220. Thecross-member 1214 can also be pivotably connected to the distal end ofthe inner members 1212 at a second end (opposite to the first end) ofthe cross-member 1214, forming a fourth pivotable joint 1222. The outermember 1210 can also comprise an opening 1224, allowing the inner member1212 and the cross-member 1214 to extend through the outer member 1210when the device in the leaflet capture configuration, as shown in FIG.60.

Although not shown, the spacer body can comprise an annular metal frame(similar to frame 28) covered with a blood-impervious fabric (similar tofabric 1128). The frame can comprise a mesh-like structure comprising aplurality of interconnected metal struts or can comprise a metal braid.The frame can be formed from a self-expandable material, such asNitinol. In other embodiments, the frame can be formed from aplastically expandable material, such as stainless steel or a cobaltchromium alloy.

Due to the adjustable nature of the anchor 1202 and the flexible natureof the spacer body, the device 1200 can be radially compressed to adelivery configuration (FIG. 59). As shown, the cross-member 1214 can beconfigured to nest within inner member 1214, and the inner member can beconfigured to nest within the outer member 1210, thereby reducing theprofile of the device 1200 in the delivery configuration.

Although not shown, the device 1200 can be delivered percutaneously to anative heart valve (e.g., the mitral valve) with a delivery apparatus,for example, using the transseptal technique described for device 1100(shown in FIGS. 54-58). FIG. 59 shows the device in the deliveryconfiguration (similar to device 1100 in FIG. 54). FIG. 60 shows thedevice 1200 in the leaflet-capture configuration (similar to device 1100in FIGS. 55-56). FIG. 61 shows the device 1200 in the functional orleaflet-secured configuration (similar to device 1100 in FIGS. 57-58).

Delivery Systems and Devices

Delivery systems and/or devices used to percutaneously deliverprosthetic implant devices (e.g., prosthetic spacer devices) cancomprise introducer sheaths, one or more catheters (e.g., outer, guide,and/or implant catheters), and other devices. Generally, an introducersheath can be inserted into a patient's body which provides an accesspoint for other devices (e.g., catheters) to be introduced into thepatient's body. For example, during a transseptal procedure, anintroducer sheath can be inserted into a patient's right femoral veinthrough which an outer catheter can be inserted. The outer catheter canbe advanced through the femoral vein, up the vena cava, and into theright atrium. The septum is then punctured with the outer catheter suchthat the outer catheter extends into the left atrium. The outer cathetercan then be parked at the septal opening.

A middle or guide catheter can be inserted through the outer catheter toachieve the desired positioning for the respective procedure. Forexample, the guide catheter can be used to achieve the positioning withrespect to the mitral valve. In particular embodiments, the guidecatheter can also serve as the implant catheter configured to advance aprosthetic device through the patient's vasculature and deploy theprosthetic device at the desired implantation location. For example, thedistal end portion of the guide catheter can comprise a delivery sheathconfigured to retain a prosthetic device in a compressed delivery statewhile advanced through the patient's body. In alternative embodiments,an inner or implant catheter can be inserted through the guide catheterto deploy, secure, and release a prosthetic implant device.

Some embodiments of the delivery systems disclosed herein allow theimplant catheter to be either pre-loaded (i.e., inserted through theguide catheter prior to the guide catheter being advanced the outercatheter), or loaded during the procedure (i.e., inserted through guidecatheter after the guide catheter is advanced into the left side of apatient's heart). Some embodiments of the delivery systems disclosedherein comprise a middle or guide catheter with a flexible, steerabledistal portion and a control member on or adjacent the handle which canbe used to bend, flex, and/or orient the distal portion. Some of thedisclosed delivery systems comprise various locking, rotation and/oranti-rotation, and or coupling features.

The delivery systems disclosed herein can, for example, significantlyimprove a physician's ability to desirably orient and secure thecatheters used, for example, in a transseptal procedure used to implanta prosthetic implant device. These systems can also, for example,significantly improve the safety, duration, and effectiveness of aprosthetic implant placement procedure.

FIG. 62 shows an exemplary steerable, flexible prosthetic implantdelivery device 1300, according to one embodiment. In the illustratedembodiment, the delivery device 1300 generally comprises an implantcover or sheath 1302, a flexible, radially expandable basket portion1304, an intermediate shaft 1306, a basket expander mechanism 1308, aproximal shaft 1310, a steering control member 1312, a plurality ofbasket expander wires 1314 (four in the illustrated embodiment, but onlytwo shown in FIG. 62), and a plurality of steering control wires 1316(four in the illustrated embodiment, but only two shown in FIG. 62).

The basket portion 1304 of the delivery device 1300 can be disposedbetween the sheath 1302 and the intermediate shaft 1306. The basketportion 1304 can be fixedly secured or coupled (e.g., with an adhesive,fasteners, etc.) to the sheath 1302 at a first, distal end of the basketportion 1304 and fixedly secured or coupled to the intermediate shaft1306 at a second, proximal end of the basket portion 1304. The expandermechanism 1308 can be disposed between the intermediate shaft 1306 andthe proximal shaft 1310. The expander mechanism 1308 can be connected tothe intermediate shaft 1306 at a first, distal end of the expandermechanism 1308 and to the proximal shaft 1310 at a second, proximal endof the expander mechanism 1308, as further described below.

The steering control member 1312 can be proximally disposed on theproximal shaft 1310, relative to the expander mechanism 1308. The basketexpander wires 1314 can extend co-axially through the sheath 1302, thebasket portion 1304, the intermediate shaft 1306, the basket expandermechanism 1308, and the proximal shaft 1310. The expander wires 1314 canbe fixedly secured (e.g., with an adhesive) to the sheath 1302 at first,distal ends 1318 of the respective expander wires 1314, and to theproximal shaft 1306 at second, proximal ends 1320 of the respectiveexpander wires 1314.

The control wires 1316 can extend co-axially through the sheath 1302,over the basket portion 1304, and through the intermediate shaft 1306,the expander mechanism 1308, and the proximal shaft 1310. The controlwires 1316 can be fixedly secured to the sheath 1302 at first, distalends 1322 of the respective control wires 1316 and to the control member1312 at second, proximal ends 1324 of the respective control wires 1316.

The sheath 1302 of the delivery device 1300 can be configured to receivevarious prosthetic implant devices and/or retain a prosthetic implantdevice in a delivery configuration. For example, the sheath 1302 canreceive a prosthetic spacer device (e.g., the prosthetic spacersdescribed herein) and retain the prosthetic device in a deliveryconfiguration (as shown in FIG. 67). The sheath 1302 can also, forexample, receive a prosthetic heart valve, stent, etc.

The basket 1304 of the delivery device 1300 can be expandable such thatthe basket 1304 can be placed in a non-expanded delivery configuration(best shown in FIG. 63b ), allowing the device 1300 to have a relativelysmall profile when space is limited (e.g., when passing through anothercatheter or a vessel). When the space is not as limited (e.g. whenadvanced out of another catheter into the left atrium or another chamberof a heart), the basket 1304 can be radially expanded to a functionalconfiguration (best shown in FIG. 64). The basket 1304 impartsflexibility to the distal end portion of the device thereby providing aphysician with a greater range of motion and steerability at the distalend of the device 1300 and thus greater control of a prosthetic implantdevice during an implant placement procedure. In particular embodiments,the basket 1304 comprises a mesh or braided construction, such as apolymer braid (e.g. nylon) or a metal braid (e.g., Nitinol or stainlesssteel).

As best shown in FIG. 65A, the intermediate shaft 1306 of the deliverydevice 1300 can comprise a centrally disposed (relative to thelongitudinal axis of the device) implant or working lumen 1326 and aplurality of wire lumens 1328 (eight in the illustrated embodiment)disposed radially outward from and distributed annularly around theimplant lumen 1326 within the sidewall of the shaft. The wire lumens1316 can be angularly spaced from each other by approximately 45degrees. The respective lumens 1326, 1328 can extend axially through theintermediate shaft 1306.

The implant lumen 1326 can, for example, allow a device implant catheter(not shown, but similar to implant catheter 214) to be inserted throughthe implant lumen 1326. The wires 1314, 1316 can each extend through arespective wire lumen 1328. The four expander wires 1314 can occupy fourof the wire lumens 1328 in an every-other lumen pattern, such that theexpander wires 1314 are spaced apart from each other approximately 90degrees. The four control wires 1316 can occupy the four remainingunoccupied lumens 1328 in an every-other lumen pattern, such that thecontrol wires 1316 are spaced apart from each other approximately 90degrees

As shown in FIG. 62, the intermediate shaft 1306 can also comprise aplurality of radially extending side openings or ports 1330 (four in theillustrated embodiment, but only two shown in FIG. 62) located towardthe distal end of the intermediate shaft 1306 but proximal to the basket1304. The ports 1330 can be distributed circumferentially around theintermediate shaft 1306 (e.g., spaced apart from each other by 90degrees), and configured to correspond with the wire lumens 1328 thatare occupied by the control wires 1316, thereby allowing the controlwires 1316 to enter respective wire lumens 1328 via respective sideopenings 1330. The intermediate shaft 1306 can be formed from abiocompatible polymer such as polyether block amide (e.g., Pebax®).

The intermediate shaft 1306 can include different axial sections thatvary in hardness and/or rigidity. For example, as shown in FIG. 65b ,the intermediate shaft can include a first, distal section 1332 and asecond, proximal section 1334. The distal section 1332 of theintermediate shaft 1306 can, for example, comprise a softer materialrelative to the material of the proximal section 1334 of theintermediate shaft 1306. In some embodiments, for example, the sections1332, 1334 of the intermediate shaft 1306 can comprise Pebax® with ShoreD hardness values of 55 and 72, respectively. An intermediate shaft witha softer distal end can, for example, allow the distal end of theintermediate shaft 1306 to bend and/or flex more easily without kinkingor otherwise plastically deforming.

The basket expander mechanism 1308 of the delivery device 1300 cancomprise a distal nut 1338, a proximal nut 1340, and an outer nut orsleeve 1342, as shown in FIG. 62. The distal nut 1338 can be fixedlysecured to the proximal end of the intermediate shaft 1306 and compriseexternal threads oriented in a first direction. The proximal nut 1340can be fixedly secured to the distal end of the proximal shaft 1310 andcomprise external threads oriented in a second direction, the seconddirection being opposite to the first direction of the threads of thedistal nut 1338. The outer nut 1342 can comprise first internal threads1344 along the distal end portion of the outer nut 1342 corresponding toand engaging the threads of the distal nut 1338 and second, proximalinternal threads 1346 along the proximal end portion of the outer nut1342 corresponding to and engaging the threads of the proximal nut 1340.

In use, rotation of the outer nut 1342 relative to the distal nut 1338and the proximal nut 1340 in a first direction causes the distal and theproximal nuts 1338, 1340 and thus the intermediate shaft 1306 and theproximal shaft 1310 to move toward each other, and rotation of therotation of the outer nut 1342 relative to the distal nut 1338 and theproximal nut 1340 in a second direction (opposite the first direction)causes the distal and the proximal nuts 1338, 1340 and thus theintermediate shaft 1306 and the proximal shaft 1310 to move away fromeach other, similar to a turnbuckle.

Rotation of the outer nut 1342 relative to the distal nut 1338 and theproximal nut 1340 in the first direction, causing the intermediate shaft1306 to move towards the proximal shaft 1310 in the proximal direction,also moves the intermediate shaft 1306 away from the sheath 1302 in theproximal direction. And, rotation of the outer nut 1342 relative to thedistal nut 1338 and the proximal nut 1340 in the second direction,causing the intermediate shaft 1306 to move away from the proximal shaft1310 in the distal direction, moves the intermediate shaft 1306 towardsthe sheath 1302 in the distal direction.

Due to the flexible nature of the basket 1304, rotation of the outer nut1342 relative to the distal nut 1338 and the proximal nut 1340 in thefirst direction (i.e., moving the intermediate shaft 1306 proximallyaway from the sheath 1302) causes the basket 1304 to axially elongateand radially compress to the delivery configuration (shown in FIG. 63b). Rotation of the outer nut 1342 relative to the distal nut 1338 andthe proximal nut 1340 in the second direction moving the intermediateshaft 1306 distally towards the sheath 1302) causes the basket toaxially foreshorten and radially expand to the functional configuration(shown in FIGS. 62, 64, 67).

The proximal shaft 1310 of the delivery device 1300 can have aconstruction that is substantially similar to that of the intermediateshaft 1306, including a centrally disposed (relative to the longitudinalaxis) implant lumen 1348 (shown in FIG. 66) and a plurality of wirelumens (not shown, but similar to wire lumens 1328) (eight in theillustrated embodiment) disposed radially outward from and distributedcircumferentially around the implant lumen. 1348 within the side wall ofthe shaft 1310. The respective implant and wire lumens can extendco-axially through the proximal shaft 1310. The respective implant andwire lumens of the proximal shaft 1310 and the intermediate shaft can beconfigured so as to be axially aligned, allowing the wires 1314, 1316 toextend axially through the shafts 1306, 1310.

As shown in FIG. 62, the proximal shaft 1310 can also comprise aplurality of radially extending side openings or ports 1350 (four in theillustrated embodiment, but only two shown in FIG. 62) that are incommunication with the lumens 1328 containing the control wires 1316.The side openings 1350 can be radially aligned with the ports 1330 ofthe intermediate shaft 1306. The ports 1350 of the proximal shaft 1310can be disposed on the proximal shaft 1310 between the proximal nut 1340of the basket expander mechanism 1308 and the control member 1312,allowing the control wires 1316 to exit the irrespective wire lumens1328 of the proximal shaft 1310 via respective side openings 1350. Theproximal shaft 1310 can be formed from a biocompatible polymer. Forexample, the proximal shaft 1310 can comprise Pebax with a Shore Dhardness value of 72.

The steering control member 1312 of the delivery device 1300 cancomprise a pivotable control handle 1352 and fixed sleeve portion 1354.The sleeve portion 1354 can be proximally disposed on and fixedlysecured to the proximal shaft 1310, relative to the side ports 1350 ofthe proximal shaft 1310. The sleeve portion can comprise a spherical orat least partially spherical outer surface 1356. The control handle 1352can comprise a socket portion 1358 (FIG. 62) disposed around theexternal surface 1356 of the sleeve 1354. In this manner, the externalsurface 1356 serves as a ball of a ball-in-socket joint formed with thesocket portion 1358. This allows the socket 1358 and thus the controlhandle 1352 to be pivotable relative to the ball 1356.

The control handle 1352 can also comprise a plurality of axiallyextending openings 1360 (four in the illustrated embodiment, see FIG.66) disposed radially outward on control handle 1352, relative to thesocket 1358, configured to receive the proximal ends 1324 of respectivecontrol wires 1316, and thereby allowing the proximal ends 1324 of thecontrol wires 1316 to be secured to the handle 1352. The openings 1360can be angularly spaced apart from each other around the handle 1352,for example by approximately 90 degrees.

In some embodiments, as shown, the proximal ends 1324 of the respectivecontrol wires 1316 can be secured to the handle 1352 by inserting theproximal ends 1324 of the wires 1316 through respective openings 1360and attaching respective end caps or ferrules 1362 to the proximal ends1324 of the respective control wires 1316 which have a diameterexceeding the diameter of the openings 1360, thereby preventing theproximal ends 1324 of the control wires 1316 from retracting through theopenings 1360. In other embodiments, the proximal ends 1324 of thecontrol wires 1316 can, for example, be secured within the opening 1360and thus to the handle 1352 by an adhesive. In some embodiments, thehandle 1352 can be formed from a polymeric material such as acetal(e.g., Delrin®). In some embodiments, the sleeve 1354 can be formed froma polymeric material such as polycarbonate.

The opposite ends 1318, 1320 of the expander wires 1314 of the device1300 can be fixedly secured to the sheath 1302 and the proximal shaft1310, respectively. The wires 1314 desirably are evenly spaced apartfrom each other around the longitudinal axis of device, such as by 90degrees. Also, the expander wires 1314 can each be substantially thesame length axially and can be tensioned equally. Evenly distributingthe expander wires 1314 circumferentially and providing substantiallyuniform tension on the expander wires 1314 can allow the sheath 1302,the intermediate shaft 1306, and the proximal shaft 1310 to maintainaxial alignment when the basket 1304 expands upon adjustment of thebasket expander mechanism 1308, as described above.

Similarly, the opposite ends 1322, 1324 of the control wires 1316 of thedevice 1300 can be fixedly secured to the sheath 1302 and the handle1352, respectively. The control wires 1316 desirably are evenly spacedapart from each other around the longitudinal axis of the device, suchas by 90 degrees. Also, the control wires 1316 can each be substantiallythe same length axially and can be tensioned equally. The length of thecontrol wires 1316 can be selected such the control wires 1316 cancomprise slack when the basket 1304 is in the axially elongate deliveryconfiguration (FIG. 63b ) and can be taut when the basket 1304 is in theradially expanded functional configuration.

Evenly distributing the control wires 1316 circumferentially andproviding substantially uniform tension on the control wires 1316 can,for example, provide multi-directional control of the sheath 1302 andthus an implant device by pivoting (e.g., forward, backward, and/orside-to-side) the handle 1352 around the ball 1356. For example,referring to FIG. 62, pivoting the handle 1352 such that the upperportion of the handle 1352 moves proximally (i.e., in the direction ofarrow 1374), is effective to pull the proximal ends 1324 of the uppercontrol wires 1316 proximally, which in turn causes the sheath 1302 topivot upwardly relative to the intermediate shaft 1306, in the directionof arrow 1376. To move the distal end of the sheath 1302 downwardly, aphysician can pivot the handle 1352 of the control member 1312 such thatthe lower portion of the handle 1352 moves proximally (i.e., in thedirection of arrow 1375), which is effective to, pull the proximal ends1324 of the lower control wires 1316 proximally, which in turn causesthe distal end of the sheath 1302 to pivot downwardly relative to theintermediate shaft 1306, in the direction of arrow 1378.

The delivery device 1300 can be used, for example, to percutaneouslydeliver a prosthetic implant. For example, FIG. 67 shows the deliverydevice 1300 being used to deliver a prosthetic spacer device 1364 intothe mitral valve 1366 of a heart 1368. With a prosthetic implant devicepre-loaded into the sheath 1302, the delivery device 1300 can beadvanced through an outer catheter 1370 into the left atrium 1371 of theheart 1368. With the sheath 1302, the basket 1304, and the intermediateshaft 1306 of the device 1300 in the left atrium, the basket 1304 can beexpanded to the functional configuration by rotating the outer nut 1342of the basket expander 1308 so as to move the intermediate shaft 1306toward the sheath (described in greater detail above). Expanding thebasket 1304 of the device 1300 brings the control wires 1316 taut andallows the physician to then desirably orient the prosthetic spacerdevice 1364 by pivoting the handle 1352 of the control member 1312. Forexample, the physician can cause the sheath 1302 to make a 90 degreeturn, relative to the outer catheter 1370, to align the prostheticspacer device 1364 with the patient's mitral valve 1366.

Once the prosthetic device 1364 is desirably oriented, the prostheticspacer device 1364 can be advanced from the sheath 1302 of the device1300 and thereafter secured to the native leaflets 1372 of the mitralvalve 1366, such as previously described with respect to the prostheticspacer devices herein described. Subsequently, the basket 1304 can beradially compressed back to the delivery configuration by actuating thebasket expander mechanism 1308, thus allowing the delivery device 1300to be retracted into the outer catheter 1370 and removed from thepatient.

The implant lumens 1348, 1326 of the shafts 1310, 1306 (respectively)can, for example, advantageously allow a physician to introduceadditional catheters (e.g., an implant catheter) during a procedurewithout having to retract the delivery device from the patient. Theseadditional catheters which are introduced through the implant lumens1348, 1326 can, for example, be used to deploy a prosthetic spacerdevice.

FIG. 68 shows another exemplary steerable prosthetic implant deliverydevice 1400, according to another embodiment. The delivery device 1400can comprise a flexible inner shaft 1402, an intermediate shaft 1404, aslidable outer shaft 1406, a steering control member 1408, a wiretensioner 1410, a plurality of pivot control wires (not shown, butsimilar to wires 1316), and a hemostasis seal 1412 (e.g., tapered Luerfitting). The inner shaft 1402, the intermediate shaft 1404, and theouter shaft 1406 can extend co-axially through the control member 1408and the tensioner 1410, respectively. The inner shaft 1402 and theintermediate shaft 1404 can extend co-axially through the outer shaft1406, and the inner shaft 1402 can also extend co-axially through theintermediate shaft 1404. The inner shaft 1402 can be fixedly secured(e.g., with an adhesive) to the intermediate shaft 1404. The outer shaft1406 can be disposed around and axially moveable (i.e., distally orproximally) relative to the intermediate shaft 1404.

The control member 1408 of the delivery device 1400 can comprise a ball1414, a handle 1416, and a ring 1418 (FIG. 69). The ball 1412 can bedisposed around and fixedly secured (e.g., with an adhesive) to thedistal end of the outer shaft 1406. The handle 1416 can be disposedaround and pivotably connected to the ball 1414. The ring 1418 can bedisposed within an annular notch or groove 1420 formed within the outersurface of the handle 1416.

The plurality of pivot control wires (not shown) of the delivery device1400 can, for example, include four pivot control wires similar to thecontrol wires 1316. The control wires can have first, distal ends befixedly secured or attached to the distal end 1454 of the inner shaft1402 and second, proximal ends fixedly secured or attached to the ring1418 and thus the handle 1416. The control wires can be annularlydistributed around the central axis of the inner shaft 1402 and thehandle 1416, spaced apart from each other by 90 degrees in a mannersimilar to the control wires 1316, described above in connection withthe sheath 1302 and the control handle 1352 (FIGS. 62, 66). The controlwires can extend proximally through respective lumens of the inner shaft1402, and outwardly through respective exit ports (in shown) in theinner and intermediate shafts 1402, 1404 where the proximal ends of thecontrol wires can be attached to the ring 1418. The ports of the innershaft 1402 can be oriented so as to align circumferentially withrespective ports of the intermediate shaft 1404.

The control member 1408 and the pivot control wires can, for example,allow a physician to control the distal end 1456 of the flexible tube1402 by pivoting the handle 1416 relative to the ball 1414 in a mannersimilar to that described above with respect to delivery device 1300.Sometimes, during use, the control wires can become undesirablyslackened due to, for example, pivoting the handle 1416 and to extremeorientations, which can reduce the effectiveness of the handle 1416 tocontrol the distal end 1456 of the flexible tube 1402. To alleviateand/or eliminate this problem, the delivery device 1400 can, forexample, comprise a tensioner 1410 to remove undesirable slack in thecontrol wires, as further described below.

The tensioner 1410 of the delivery device 1400 can comprise a nut guideadapter 1422, a drive nut 1424, a stop washer 1426, a wire tensionadjustment knob 1428, an adjustment nut washer 1430, and an end cap1432. The guide nut 1422 can be fixedly secured to the proximal end ofthe outer shaft 1406. The guide nut 1422 can comprise external threads(not shown) which can be configured to engage corresponding internalthreads (not shown) of the drive nut 1424. The drive nut 1424 can alsocomprise external threads (not shown) corresponding to and engaging theinternal threads (not shown) of the wire tension adjustment knob 1428.

The adjustment knob 1428 can be coupled to and rotatable relative to theend cap 1432. The end cap 1432 can be fixedly secured or coupled to theproximal ends of the inner shaft 1402 and the intermediate shaft 1404.In this manner, rotation of the adjustment knob 1428 relative to theguide nut 1422 and the drive nut 1424 in a first direction causes thenuts 1422, 1424 and thus the outer shaft 1406, ball 1414, and handle1416 to move proximally, relative to the inner and intermediate shafts1402, 1404. Rotation of the adjustment knob 1428 relative to the nuts1422, 1424 in a second direction (opposite the first direction) causesnuts 1422, 1424 and thus the outer shaft 1406, ball 1414, and handle1416 to move distally, relative to the shafts 1402, 1404. Thus, becausethe control wires are fixed to the sheath at the distal ends of thewires and to the handle 1416 at the proximal ends of the wires, rotatingthe adjustment knob 1428 in the first direction applies tension to thecontrol wires and reduces the slack in the control wires. It should benoted that the tensioner 1410 can, for example, be used on variousdelivery devices, including the delivery device 1300.

The inner shaft 1402 of the device 1400 can comprises a slotted metaltube 1438, as shown in FIGS. 70a-71h . The metal tube 1438 can beformed, for example, by laser cutting an alloy tube (e.g., Nitinol,stainless steel, cobalt chromium, etc.). As best shown in FIG. 71b , thetube 1438 can comprise a plurality of spine portions 1440 and aplurality of struts 1442 disposed between and interconnecting the spineportions 1440. The tube 1438 can also comprise an annular collar 1444disposed at the distal end of the tube 1438.

The tube 1438 can be coated, both externally and internally, with aflexible polymeric coating. The spine portions 1440 of the tube 1438 cancomprise openings 1446 (FIG. 71b ) which can, for example, allow thepolymeric coating to evenly distribute throughout the tube 1438,providing a desirably uniform wall thickness for the inner shaft 1402.

The tube 1438 can be configured such that the spine portions 1440 formaxially extending rows 1454 that are separated by the struts 1442. Forexample, in the illustrated embodiment (best shown in FIG. 71b ), thespine portions 1440 are configured in four axially extending rows 1454a, 1454 b, 1454 c, 1454 d (in FIGS. 70b and 71b , the row 1454 d is cutaxially down the center to show the tube 1438 in a flat configurationfor illustrative purposes). The rows 1454 a-1454 d can be angularlyspaced apart from each other (e.g., by 90 degrees), and the rows 1454can be configured such that the spine portions 1440 of the rows 1454 areaxially offset relative to the spine portions 1440 of a radiallyadjacent rows 1454. Configuring the tube 1438 in this manner allows thetube 1438 to flex or bend more uniformly in all directions and reduceskinking when compared to a solid tube or a tube with a single, solidspine portion.

The collar 1444 of the tube 1438 can comprise distally extending tabs1446 (two in the illustrated embodiment). In an embodiment in which thecontrol wires are not fixedly secured or attached directly to the distalend 1456 of the flexible shaft 1402 but are attached to a separate pullring (not shown), the tabs 1446 can be used, for example, to orient thetube 1438 with the pull ring. The pull ring can be attached to thedistal end 1456 of the flexible shaft 1402, for example, by insertingthe tabs 1446 into pull ring. In such an embodiment, the collar 1444 ofthe tube 1438 can also comprise radially extending side notches or ports1436 (four in the illustrated embodiment) which can, for example, beused to allow the control wires to enter the tube 1438 and pass throughthe inner diameter of the flexible tube 1402.

The tube 1438 of the inner shaft 1402 can also comprise different axialsections (three in the illustrated embodiment) 1448, 1450, 1452, as bestshown in FIGS. 70a-70b . The different axial sections 1448, 1450, 1452can, for example, comprise differently sized struts 1442. Providingdifferently sized struts 1442 (i.e., removing more or less material),allows different axial sections to have either a smaller or larger bendradiuses. For example, the distal section 1448 comprises the thinneststruts (i.e., the most material removed) compared to the more proximalsections 1450, 1452, allowing distal section 1448 to have the smallestbend radius, relative to more proximal sections 1450, 1452. Also, theintermediate section 1450 has thinner struts than the proximal section1452, allowing the intermediate section 1450 to have a smaller bendradius than the proximal section. It should be noted that although theillustrated embodiment shows the smallest struts located distally andthe largest struts located proximally, relative to the other sections,the axial sections can be configured in any order or combination toachieve the desired result for a particular application.

FIGS. 72-74 show an exemplary embodiment of a control member 1500,similar to control members 1312, 1408 of the delivery devices 1300,1400, respectively. In the illustrated embodiment, the control member1500 comprises a ball 1502, a socket 1504, and at least one clip 1506(two in the illustrated embodiment). The socket 1504 can comprise afirst socket portion 1504 a and a second socket portion 1504 b. Thesocket portions 1504 a, 1504 b can be separated, radially, by the clips1506. The ball 1502 can comprise an inner opening or lumen 1522, whichcan allow other devices (e.g. a catheter tube, etc.) to pass through theball 1502. The socket 1504 can be disposed around the ball 1502 suchthat the socket is rotatable relative to the ball (similar to aball-joint).

The socket portions 1504 a, 1504 b can comprise at least one radiallyextending cut-out or recessed portion 1508 (two in the illustratedembodiment) (FIG. 73) configured to receive a respective clip 1506. Eachrecessed portion 1508 can contain a respective projection 1510. Theclips 1506 can be positioned within the recessed portions 1508. Theclips 1506 can each comprise a ball-contact surface 1512, a groove orslot 1514 (FIGS. 73-74), and tabs 1516.

The control member 1500 can further include a securing mechanism 1526(FIG. 74) that extends annularly around the socket portions 1504 a, 1504b and the clips 1506 that holds the socket portions 1504 a, 1504 b andthe clips 1506 together and presses the socket portions 1504 a, 1504 band the clips 1506 radially inward against the ball 1504. The securingmechanism 1526 can, for example, be one or more biasing elements (e.g.,O-rings or elastic bands) placed within grooves 1518, 1520 of the socketportions 1504 a, 1504 b and the clips 1506, respectively. In anotherembodiment, the securing mechanism can be, for example, a spring or anyother force applying mechanism.

The ball-contact surface 1512 can be configured to press against andapply a frictional force on the outer surface of the ball 1502 to resistmovement of the socket 1504 relative to the ball 1502 when manualpressure is removed from the socket 1504 and the clips 1506. The grooves1514 of the clips 1506 can be positioned to abut the projections 1510,thereby allowing the clips 1506 to pivot about the projections 1510 withthe projections 1510 acting as the fulcra. The clips 1506 can be pivotedby squeezing or pinching the tabs 1516 together (in the direction ofarrows 1528 in FIG. 74), causing the tabs 1516 to move radially inward.Pivoting the clips 1506 in this manner moves the ball-contract surface1512 radially outward away from the outer surface of the ball 1502,thereby allowing the socket 1504 and the clips 1506 to rotate relativeto the ball 1502. Releasing manual pressure from the tabs 1516 allowsthe clips 1506 to move back in contact with the ball under the biasingforce of the securing mechanism 1526.

Thus, the clips 1506 of the control member 1500 can function as alocking mechanism for securing the control member 1500 in a desiredorientation. For example, when using the control member 1500 as part ofa delivery device (e.g., delivery devices 1300, 1400), a physician cansqueeze the tabs 1516 of the clips 1506 and pivot the socket portions1504 (relative to the ball 1502), pulling the control wires (e.g.,control wires 1316) and thus the sheath (e.g., sheath 1302) (asdescribed above) to a desired orientation. The physician can then lockthe socket portions 1504 and thus the sheath in the desiredconfiguration by releasing the tabs 1516, allowing the ball-contactsurface 1512 of the clips 1506 to press against the ball 1502 and resistmovement of the socket portions 1504 relative to the ball 1502, therebyretaining the sheath in the desired orientation. This canadvantageously, for example, allow a physician to orient the deliverydevice to a desired configuration with one hand, subsequently releasethat hand from the delivery device and then use both hands to performanother task (e.g., deploying a prosthetic implant with an implantcatheter).

FIG. 75 shows another exemplary embodiment of a control member 1600,similar to control member 1500, including a ball 1602, a socket 1604,and clips 1606. The ball 1602 can comprise an inner opening or lumen1620, which can allow the ball to be mounted on the shaft of a deliverydevice. The sockets 1604 can comprise recessed portions 1608 configuredto receive the clips 1606, the recessed portions 1608 housing rods orshafts 1610. The clips 1606 each comprise ball-contact surfaces 1612,grooves or slots 1614, and tabs 1616.

The sockets 1604 can further comprise grooves (not shown, but similar togrooves 1518), and the clips 1606 can further comprise grooves 1618. Thegrooves in the sockets 1604 and the clips 1606 (i.e., grooves 1618) canbe configured to receive a securing mechanism (e.g., O-ring, spring,etc.) to hold the sockets 1604 and clips 1606 together and against theball 1602. The control device 1600 can function in a mannersubstantially similar to control member 1500, as described above. As aresult, the control member 1600 can, for example, provide similarlocking-type features and advantages described with respect to controlmember 1500.

FIGS. 76-79 show an exemplary embodiment of a control member 1700,similar to control member 1600, including a ball 1702, a socket portion1704, and clips 1706. The illustrated embodiment can be “unlocked”(i.e., allowing the socket portion 1704 to rotate relative to the ball1702) and “locked” (i.e., preventing the socket portion 1704 fromrotating relative to the ball 1702) in a manner similar to the controlmember 1600.

The ball 1702 of control member 1700 can comprise a plurality of pins orprojections 1708 (four in the illustrated embodiment) disposed on andextending radially outward from the outer surface of the ball 1702. Thesocket portion 1704 can comprise axially extending recessed portions1710 (two in the illustrated embodiment) (FIGS. 78-79) and guide rails1712 disposed within the recessed portions, with the guide rails 1712dividing the recessed portions 1710 into two tracks or channels 1714(FIGS. 78-79). The channels 1714 can be configured such that theprojections 1708 of the ball 1702 can travel or move axially within thesocket 1704 as the socket 1704 pivots about the ball 1702.

Due to the positioning of the projections 1708 of the ball 1702 in theguide rails 1712 of the socket 1704, however, the socket 1704 cannottorque or rotate annularly, relative to the ball 1702. Thisanti-torquing feature of the control member 1700 advantageouslyprevents, for example, a physician from torquing the socket 1704 andthus twisting the control wires (not shown). These features can, forexample, make the control member 1700 and thus a delivery device easierto operate because the socket 1704 can only move in an intended manner.This anti-torquing feature can also, advantageously, for example, reducethe possibility that a physician will inadvertently damage the controlmember 1700 and/or the delivery device by using the control member in anunintended manner.

FIGS. 80-82 show an exemplary embodiment of a control member 1800,similar to control member 1600, including a ball 1802, a socket portion1804, and clips 1806. The illustrated embodiment can be “unlocked”(i.e., allowing the socket portion 1804 to rotate relative to the ball1802) and “locked” (i.e., preventing the socket portion 1804 fromrotating relative to the ball 1802) in a manner similar to the controlmember 1600.

The ball 1802 of control member 1800 can comprise a plurality of pins orprojections 1808 (two in the illustrated embodiment) disposed on andextending radially outward from the outer surface of the ball 1802. Thesocket portion 1804 can comprise axially extending recesses or channels1810 (two in the illustrated embodiment) configured to receive theprojections 1808 such that the projections 1808 can travel or moveaxially within the socket 1804 as the socket 1804 pivots about the ball1802. However, due to the positioning of the projections 1808 in thechannel 1810, the socket portion 1804 cannot torque or rotate annularly,relative to the ball 1802. This anti-torquing feature can, for example,provide at least the advantages described with respect to control member1700.

FIGS. 83-85 show an exemplary control member 1900, according to oneembodiment. The control member 1900 can function, for example, in amanner substantially similar to control member 1408 of device 1400. Inthe illustrated embodiment, the control member 1900 comprises a ball1902, a socket portion 1904, and a lock 1906. The socket 1904 cancomprise a generally spherically-shaped surface (not shown) disposedaround the ball 1902 (similar to a ball-joint), an externally-threadedportion 1908 at the proximal end of the socket 1904, and a flange orhandle portion 1910 extending radially from the distal end of theexternally-threaded portion 1908, as best shown in FIG. 83.

The lock 1906 can comprise a generally spherically-shaped interiorsurface 1912 having internal threads, configured to receive theexternally-threaded portion 1908 of the socket 1904, and a knob 1914disposed radially outward from the surface 1912. In this manner,rotation of the knob 1914 and thus the lock 1906 relative to the ball1902 and the socket 1904 in a first direction moves the socket 1904 andthe lock 1906 axially towards each other, urging the surface 1912 of thelock 1906 against the ball 1902, and thereby preventing the socket 1904from pivoting or rotating relative to the ball 1902 (i.e., “locking” thesocket 1904); and rotation of the knob 1914 in a second direction (thesecond direction being opposite the first) moves the socket 1904 and thelock 1906 axially towards away from each other, removing the surface1912 of the lock 1906 from the ball 1902, and thereby allowing thesocket 1904 to pivot or rotate relative to the ball 1902 (i.e.,“unlocking” the socket 1904).

FIGS. 86-87 show an exemplary catheter-position locking device 2000,according to one embodiment. In the illustrated embodiment, the lockingdevice 2000 comprises a coupler or sleeve 2002 (best shown in FIG. 87),a housing 2004, and a fastener portion 2006. As best shown in FIG. 87,the sleeve 2002 can extend co-axially over a distal shaft portion 2005of the housing 2004. The housing 2004 can comprise an axially extendinglumen 2008 and a radial opening (not shown), the radial opening beinggenerally perpendicular to the lumen. 2008 and comprising internalthreads. The fastener 2006 can comprise an externally-threaded plug 2010that engages the internal threads of the radial opening of the housing2004 and can extend through the radial opening into the lumen of thehousing. The fastener 2006 can also comprise a head portion or knob 2012fixedly secured to the upper end portion of the plug 2010.

In use, rotation of the head 2012 and thus the plug 2010 in a firstdirection relative to the housing 2004 moves the plug 2010 06 radiallyinwardly, thereby obstructing the lumen 2008 of the housing 2004, androtation of the rotation of the head 2012 of the fastener 2006 in asecond direction (the second direction being opposite the first)relative to the housing 2004 moves the plug 2010 radially outwardly,thereby removing the plug 2010 from the lumen 2008 of the housing 2004.

The device 2000 can, for example, be used to allow one catheter orsheath to be desirably positioned relative to another catheter or sheathand then secured in the desirable position. For example, FIG. 87 showsthe device 2000 being used with an introducer sheath 2014 and an outercatheter 2016. In some embodiment, as shown, the device 2000 can befixedly secured or coupled to the proximal end of the introducer sheath2014 by advancing the distal end of the sleeve 2002 of the device 2000over the sheath 2014. In other embodiments, the device 2000 can befixedly secured or coupled to the proximal end of the introducer sheathby an adhesive, fasteners, etc.

With the axial opening 2008 of the device 2000 clear or open (i.e., theplug 2010 of the fastener 2006 not obstructing the axial opening 2008),the outer catheter 2016 can be advanced through the device 2000 and theintroducer sheath 2014. In this open or clear configuration, the outercatheter 2016 can torque/rotate and/or move axially (i.e., distally orproximally) relative to the device 2000 and thus the introducer sheath2014, allowing the outer catheter 2016 to be desirably positioned. Oncethe outer catheter 2016 is desirably positioned, the outer catheter canbe secured in the desirable position by rotating the head 2012 of thefastener 2006 in the first direction, causing the plug 2010 to moveinward and press against the outer catheter 2016 (as best shown in FIG.86), thereby preventing the outer catheter from torquing/rotating and ormoving axially relative to the introducer sheath 2014. Thus, the device2000 can, for example, advantageously allow a physician to both adjustand secure a catheter during a procedure, making the procedure bothsignificantly safer and easier to perform.

FIGS. 88-91 show an exemplary catheter-position locking device 2100,according to another embodiment. In the illustrated embodiment, thelocking device 2100 comprises a fixed portion 2102 and a moveableportion 2104 connected to the fixed portion 2102, with the moveableportion 2104 being rotatable relative to the fixed portion 2102. Thefixed portion 2102 of the device can comprise a centrally disposedopening 2106, an axially extending sleeve 2108 disposed radially outwardfrom the opening 2106, and circumferentially extending notches orgrooves 2110 disposed radially outward from the sleeve 2108. Themoveable portion 2104 can comprise a centrally disposed opening 2112 andaxially extending pins 2114 disposed radially outward from the opening2112. The pins 2114 of the moveable portion 2104 can be configured toaxially extend through respective grooves 2110 of the fixed portion, asbest shown in FIG. 88.

It should be noted that although the openings 2106, 2112 are shown ashaving a generally square cross-section, the openings 2106, 2112 cancomprise various other shapes.

As best shown in FIGS. 90-91, the openings 2106, 2112 of the respectiveportions 2102, 2104 can be configured such that rotating the movableportion 2104 relative to the fixed portion 2102 to a first, unlockedposition aligns the opening 2112 of the moveable portion 2104 with theopening 2106 of the fixed portion 2102 (FIG. 90). Rotating the movableportion 2104 relative to the fixed portion 2102 to a second, lockedposition causes the opening 2112 of the moveable portion 2104 to becomemisaligned with the opening 2106 such that the moveable portion 2104interferes with or partially obstructs the opening 2106 of the fixedportion 2102 (FIG. 91).

Although not shown, the device 2100 can, for example, be used with anintroducer sheath and outer catheter similar to sheath 2014 and catheter2016. The sleeve 2108 of the fixed portion 2102 of the device 2100 canbe fixedly secured or coupled (e.g., with an adhesive, fasteners, etc.)to the proximal end of the introducer sheath. With the movable portionrotated to the first, aligned position, the outer catheter can beadvanced through the device 2100 and the introducer sheath. With themovable portion 2104 in the aligned position, the outer catheter cantorque/rotate and/or move axially relative to the device 2100 and theintroducer sheath to a desirable positioning. Once desirably positioned,the moveable portion 2104 can be rotated to a second, misalignedposition causing the movable portion 2104 to press against the outercatheter, thereby preventing the outer catheter from torquing/rotatingand or moving axially relative to the introducer sheath.

FIGS. 92-96 show an exemplary catheter-position locking device 2200,according to another embodiment. In the illustrated embodiment, thelocking device 2200 comprises a shaft portion 2202, a cam portion 2204,and a handle portion 2206 comprising a rotatable knob. As best shown inFIG. 93, the shaft 2202 of the device 2000 can comprise an opening orlumen 2208 extending axially through the shaft 2202 and a flangedportion 2210 at the proximal end of the shaft 2202. FIG. 93 also showsthat the shaft portion 2202 and the cam portion 2204 can be connected byinserting the flanged portion 2210 into an annular recessed portion 2212formed in the distal end of the cam portion 2204.

The cam portion 2204 can be rotatable relative to the shaft portion2202. The cam 2204 can further comprise an annular notch or groove 2214disposed near the proximal end of the cam 2204 (FIGS. 92-93) and anoffset opening 2216 (i.e., offset or having a different axis relative tothe lumen 2208 of the shaft 2202) (best shown in FIG. 94). The handle2206 can comprise an opening 2218 extending axially through the handle2206. The handle portion 2206 can be disposed around and attached to thecam 2204 by inserting a fastener (not shown, e.g., a screw or bolt)through a corresponding radially extending and internally threaded port2220 in the handle 2206. The fastener and port 2220 can be configuredsuch that the fastener can extend through the handle 2206 and engage thecam 2204 within the groove 2214, such that the handle 2206 is fixedrelative to the cam 2204. Thus, rotating the handle 2206 rotates the cam2204.

Due to the offset opening 2216, the handle 2206 and thus the cam 2204can be rotated relative to the shaft 2202 to a first, unlocked positionwherein the opening 2216 of the cam 2204 aligns with the lumen 2208 ofthe shaft 2202 (FIG. 95) and to a second, locked position wherein theopening 2216 of the cam 2204 misaligns with the lumen 2208 of the shaft2202 such that the cam 2204 interferes or obstructs the lumen 2208 ofthe shaft 2202 (FIG. 96).

Although not shown, the device 2200 can, for example, be used with anintroducer sheath and outer catheter similar to sheath 2014 and catheter2016 in the manner shown in FIG. 87. The shaft 2202 can be fixedlysecured or coupled (e.g., with an adhesive, fasteners, etc.) to theproximal end of the introducer sheath. With the opening 2216 of the cam2204 aligned with the lumen 2208 of the shaft 2202, the outer cathetercan be advanced through the device 2200 and the introducer sheath. Inthis aligned configuration, the outer catheter can torque/rotate and/ormove axially relative to the device 2200 and the introducer sheath to adesirable positioning. Once desirably positioned, the handle 2200 can berotated to a second, misaligned position causing the cam 2204 to pressagainst the outer catheter, thereby preventing the outer catheter fromtorquing/rotating and or moving axially relative to the introducersheath.

FIGS. 97-98 show an exemplary catheter-position locking device 2300,according to another embodiment. The device 2300 comprises a lock sleeve2302 and a key shaft or tube 2304. As best shown in FIG. 98, the locksleeve 2302 comprises an axially extending opening 2306 which includesat least one tab or pin 2308 (two in the illustrated embodiment)extending radially inward within the opening 2306. The key tube 2304comprises at least one groove or notch 2310 (two in the illustratedembodiment). The notches 2310 of the key tube 2304 can be configured tocorrespond with the pins 2308 of the lock sleeve 2302 such that the keytube 2304 can be inserted and move axially within the opening of thelock sleeve 2302 by aligning the notches of the key tube 2304 with thepins 2308 of the lock sleeve 2302.

As shown, the pins 2308 of the lock sleeve 2302 and the correspondingnotches 2310 of the key tube 2304 can be symmetrically disposed aroundthe opening 2306 of the lock sleeve 2302 and the key tube 2304,respectively. When the configured symmetrically, the key tube 2304 canbe inserted into the lock sleeve 2302 in multiple orientations (twoorientations in the illustrated embodiment). Although not shown, itshould be noted that the pins 2308 of the lock sleeve 2302 and thecorresponding notches 2310 of the key tube 2304 can be asymmetricallydisposed around the opening 2306 of the lock sleeve 2302 and the keytube 2304, respectively, such that the key tube 2304 can be insertedinto the lock sleeve 2302 in only one orientation.

The device 2300 can, for example, be used with a prosthetic implantdelivery system or device to prevent one catheter from torquing orrotating relative to another catheter. For example, the device 2300 canbe used to prevent a middle or guide catheter 2312 from torquing orrotating relative to an outer catheter (not shown, but similar to outercatheter 2016), or vice versa. The lock sleeve 2302 can be fixedlysecured to the proximal end of an outer catheter. For example, thedistal end of the lock sleeve 2302 can be advanced over the proximal endof the outer catheter, the lock sleeve 2302 being fixedly secured to theouter catheter with an adhesive, fasteners, etc. The key tube 2304 canbe fixedly secured to the shaft of the guide catheter 2312.

With the lock sleeve 2302 and key tube 2304 fixedly secured to the outercatheter and the guide catheter 2312, respectively, the guide catheter2312 can be advanced through the outer catheter until the key tube 2304enters the lock sleeve 2302. In this configuration, the pins 2308 of thelock sleeve 2302 engage the notches 2310 of the key tube 2304, therebypreventing the guide catheter 2312 from torquing or rotating relative tothe outer catheter, or vice versa. Alternatively, in otherimplementations, using delivery device 1300 as an example, the key tube2304 can be fixedly secured to and disposed on the intermediated shaftbetween the basket 1304 and the basket expander 1308, preferably nearthe basket expander 1308. In another implementation, using the deliverydevice 1400 as an example, the key tube 2304 can be fixedly secured toand disposed on the intermediate shaft 1404 distal to, but preferablynear, the control member 1408.

By preventing the guide catheter from torquing or rotating, the deliverysystem can be, for example, significantly safer to use because it helpsprotect against inadvertent torquing the guide catheter during aprocedure. This makes a delivery device significantly easier to usebecause improper movement is desirably prevented or eliminated, reducingthe number of steps needed to perform a procedure, as well as wastedmovement. By bonding the key tube at a pre-set location and/ororientation on the shaft of the guide catheter, the device 2300 can alsomake the device easier to use, reduce procedure time, and/or mistakes byreducing or eliminating the need for the physician to determine how farto advance and/or orient the guide catheter relative to the outercatheter.

FIGS. 99-102 show an exemplary prosthetic implant delivery device 2400,according to one embodiment. The delivery device 2400 comprises an outershaft 2402, an annular collar or collet 2404, and an inner shaft 2406,as best shown in FIGS. 99-100. The collet 2404 can be fixedly secured orcoupled to the distal end of the outer shaft 2402, and the inner shaft2406 can extend co-axially through the outer shaft 2402 and the collet2404. The inner shaft 2406 can be axially moveable (i.e., distally orproximally) relative to the outer shaft 2402 and the collet 2404.

The collet 2404 of the delivery device 2400 can comprise a sleeveportion 2408 located at the proximal end of the collet 2404 and aplurality of prongs or tines 2410 (two in the illustrated embodiment)which extend axially away (i.e., distally) from the distal end of thesleeve portion 2408. The tines 2410 can each comprise a respectiveradial projection 2412, the projections 2412 being disposed at or nearthe distal end of the tines 2410 and extending radially outward from thetines 2410. The projections 2412 of the tines 2410 can be configured toconnect to the proximal end of a prosthetic spacer device or anotherpercutaneously delivered prosthetic device. For example, a prostheticspacer device can have a proximally disposed annular collar (similar tocollar 112) comprising a plurality of radial openings configured toreceive the projections 2412 of the delivery device 2400, therebyconnecting the prosthetic spacer to the delivery device 2400.

The collet 2404 of the delivery device 2400 can be formed from amaterial that allows the tines 2410 to be elastically expandable andcompressible in the radial direction. For example, the collet 2404 canbe formed from stainless steel. When formed from an elasticallyexpandable and compressible material, the tines 2410 can radially expandfrom a released configuration (FIGS. 101-102) to an attached or deliveryconfiguration (FIGS. 99-100) and vice versa, as further described below.

The delivery device 2400 can be used to deliver a prosthetic spacerdevice 2414 percutaneously to a native heart valve (e.g., the mitralvalve), as shown in FIGS. 99-102. The prosthetic spacer 2414 can includeanchors 2416. The delivery device 2400 can, for example, be used as partof a delivery apparatus including an outer catheter (not shown, butsimilar to outer catheter 212), middle or guide catheter (not fullyshown, but similar to guide catheters 1300, 1400), and the deliverydevice 2400.

The outer catheter can, for example, be used to cross the septal wall,the outer catheter opening into the left atrium of the heart. The middleor guide catheter comprising an implant cover or sheath 2418 can, forexample, be advanced through the outer catheter with the deliverycatheter 2400 and into the mitral valve such that the anchors 2416 arein the left ventricle, as shown in FIG. 99. The spacer 2414 can then bedeployed from within the sheath 2418 by advancing the delivery catheter2400 distally, relative to the sheath 2418, or retracting the sheathproximally relative to the delivery catheter, as shown in FIG. 100. Thedelivery device 2400 can be used to desirably position the spacer 2414relative to the native leaflets 2420. For example, the spacer 2414 canbe torqued or rotated and/or moved axially by rotating or torquingand/or advancing or retracting the outer shaft 2402, respectively.

Once the spacer 2414 is desirable positioned and secured to the nativeleaflets, the spacer 2414 can be released from the delivery device 2400.The spacer 2414 can be released from the delivery device 2400 byretracting the inner shaft 2406, relative to the collet 2404 and theouter shaft 2402, allowing the tines 2410 to radially compress and theprojections 2412 to move radially inward away from the spacer 2414 suchthat the projections 2412 disengage the spacer 2414, as shown in FIG.101. With the projections 2412 disconnected from the spacer 2414, thespacer 2414 is released, and the delivery device 2400 and the sheath2418 can be retracted through the outer catheter, as shown in FIG. 102.

If, however, the physician would like to reposition the spacer 2414after releasing the delivery device 2400, the physician can re-attachthe delivery device 2400 to the spacer 2414 by reversing theabove-described steps for releasing the spacer 2414.

FIG. 103 shows an exemplary embodiment of an annular collar or collet2500 for a delivery catheter which is similar to collet 2404 of thedelivery device 2400. The collet 2500 can comprise a sleeve 2502 and aplurality of tines 2504 (four in the illustrated embodiment) extendingaxially away from the distal portion of the sleeve 2502. As shown, eachtine 2504 can comprise a projection 2506 extending radially outward fromthe distal end of a respective tine 2504. Each projection is configuredto extend into a respective opening of the implant to be delivered. Thecollet 2500 can function and be used in a manner substantially similarto collet 2404 of delivery device 2400.

FIGS. 104-106 show another exemplary embodiment of a prosthetic implantdelivery device 2600, similar to delivery device 2400. The deliverydevice 2600 comprises an outer shaft (not shown, but similar to outershaft 2402), an annular collar or collet 2602, and an inner shaft 2604,as best shown in FIG. 104. The collet 2602 can be fixedly secured orcoupled to the distal end of the outer shaft, and the inner shaft 2604can extend co-axially through the outer shaft and the collet 2602. Theinner shaft 2604 can be axially moveable (i.e., distally or proximally)relative to the outer shaft 2402 and the collet 2404.

The collet 2602 of the delivery device 2600 can comprise a sleeveportion 2606 located at the proximal end of the collet 2602 and aplurality of prongs or tines 2608 (two in the illustrated embodiment)which extend axially away (i.e., distally) from the distal end of thesleeve portion 2606. The tines 2608 can each comprise a respectiveprojection 2610, the projections 2610 being disposed at or near thedistal end of the tines 2608 and extending radially outward from thetines 2608. The projections 2610 of the tines 2608 can be configured toconnect to the proximal end of a prosthetic implant device (e.g., aprosthetic spacer). For example, a prosthetic spacer device can have aproximally disposed annular collar 2612 comprising a plurality of radialopenings 2614 configured to receive the projections 2610 of the deliverydevice 2600.

Similar to delivery device 2400, the delivery device 2600 can be coupledto the collar 2612 of a prosthetic implant by retracting the inner shaft2604 proximally, relative to the collet 2602 and the outer shaft (notshown), such that the distal end of the inner shaft 2604 is locatedproximal within the sleeve 2606 of the collet 2602, as shown in FIG.105. Retracting the inner shaft 2604 allows the tines 2608 to radiallycompress (see FIG. 105) such that the tines 2608 can be inserted intothe collar 2612 of the prosthetic implant.

As shown in FIG. 106, the implant can be secured to the delivery device2600 by aligning the projections 2610 of the delivery device 2600 withthe openings 2614 of the implant and advancing the inner shaft 2604distally, relative to the collet 2602 and the outer shaft (not shown),such that the inner shaft 2604 extends axially through the tines 2608.Advancing the inner shaft 2604 through the tines 2608 causes the tines2608 to radially expand and forces the projections 2610 into theopenings 2612 of the implant, thus securing the implant to the deliverydevice 2600.

FIGS. 107-110 show an exemplary prosthetic implant delivery device 2700,similar to delivery device 2400, according to one embodiment. Thedelivery device 2700 comprises an outer shaft 2702, an annular collar orcollet 2704, and an inner shaft 2706, as best shown in FIGS. 109-110.The collet 2704 can be fixedly secured or coupled to the distal end ofthe outer shaft 2702, and the inner shaft 2706 can extend co-axiallythrough the outer shaft 2702 and the collet 2704. The inner shaft 2706can be axially moveable (i.e., distally or proximally) relative to theouter shaft 2702 and the collet 2704.

The collet 2704 of the delivery device 2700 can comprise a sleeveportion 2708 located at the proximal end of the collet 2704 and aplurality of prongs or tines 2710 (two in the illustrated embodiment)which extend axially away (i.e., distally) from the distal end of thesleeve portion 2708. The tines 2710 can each comprise a respectiveprojection 2712, the projections 2712 being disposed at or near thedistal end of the tines 2710 and extending radially inwardly from thetines 2710. The projections 2712 of the tines 2710 can be configured toconnect to the proximal end of a prosthetic spacer device. For example,a prosthetic spacer device can have a proximally disposed annular collar(similar to collar 112) comprising a plurality of radial openingsconfigured to receive the projections 2712 of the delivery device 2700,thereby connecting the prosthetic spacer to the delivery device 2700.

The collet 2704 of the delivery device 2700 can be formed from amaterial that allows the tines 2710 to be elastically expandable andcompressible in the radial direction. For example, the collet 2704 canbe formed from stainless steel. When formed from an elasticallyexpandable and compressible material, the tines 2710 can radially expandfrom an attached, delivery configuration (FIGS. 107-108) to a releasedconfiguration (FIGS. 109-110) and vice versa, as further describedbelow.

The delivery device 2700 can be used to deliver a prosthetic spacerdevice 2714 percutaneously to a native heart valve (e.g., the mitralvalve), as shown in FIGS. 107-110. The prosthetic spacer 2714 caninclude anchors 2716 and an annular collar 2718. The delivery device2700 can, for example, be used as part of a delivery apparatus includingan outer catheter (not shown, but similar to outer catheter 212), middleor guide catheter (not fully shown, but similar to guide catheters 1300,1400), and the delivery device 2700.

The outer catheter can, for example, be used to cross the septal wall,the outer catheter opening into the left atrium of the heart. The middleor guide catheter comprising an implant cover or sheath 2718 can, forexample, be advanced through the outer catheter with the deliverycatheter 2700 and into the mitral valve such that the anchors 2716 arein the left ventricle, as shown in FIG. 107. The spacer 2714 can then bedeployed from within the sheath 2718 by advancing the delivery catheter2700 distally, relative to the sheath 2718, or retracting the sheathproximally relative to the delivery catheter, as shown in FIG. 108. Thedelivery device 2700 can be used to desirably position the spacer 2714relative to the native leaflets 2720. For example, the spacer 2714 canbe torqued or rotated and/or moved axially by rotating or torquingand/or advancing or retracting the outer shaft 2702, respectively.

Once the spacer 2714 is desirable positioned and secured to the nativeleaflets, the spacer 2714 can be released from the delivery device 2700.The spacer 2714 can be released from the delivery device 2700 byadvancing the inner shaft 2706 distally relative to the collet 2704 andthe outer shaft 2702, causing the tines 2710 to radially expand and theprojections 2712 to move radially outwardly away from the spacer 2714such that the projections 2712 disengage from the spacer 2714, as shownin FIG. 109. With the projections 2712 disconnected from the spacer2714, the spacer 2714 is released, and the delivery device 2700 and thesheath 2718 can be retracted through the outer catheter, as shown inFIG. 110.

If, however, the physician would like to reposition the spacer 2714after releasing the delivery device 2700, the physician can re-attachthe delivery device 2700 to the spacer 2714 by reversing theabove-described steps for releasing the spacer 2714.

FIG. 111 shows an exemplary embodiment of an annular collar or collet2800 which is similar to collet 2704 of the delivery device 2700. Thecollet 2800 can comprise a sleeve 2802 and a plurality of tines 2804(four in the illustrated embodiment) extending axially away from thedistal portion of the sleeve 2802. As shown, each tine 2804 can comprisea projection 2806 extending radially inward from the distal end of arespective tine 2804. The collet 2800 can function and be used in amanner substantially similar to collet 2704 of delivery device 2700.

FIG. 112 shows a cross-sectional view of an exemplary non-circular shaft2901 of a delivery device 2900, according to one embodiment. As shown,the shaft 2901 can comprise a non-circular cross-sectional profile in aplane perpendicular to the longitudinal axis of the shaft. For example,the shaft 2901 comprises an elliptically-shaped cross-sectional profile,including a major axis (represented by dashed-line 2902) and a minoraxis (represented by dashed-line 2904). Due to the ellipticalcross-sectional shape, the delivery system 2900 can, for example, flexmore easily around the major axis 2902 than the minor axis 2904. In thismanner, the delivery device 2900 can be advanced through a tortuouspathway (e.g., vasculature) by rotating the catheter as needed at eachsuccessive bend in the pathway such that the major axis is generallyperpendicular to the direction of the bend in the pathway.

FIG. 113 shows a cross-sectional view of an exemplary non-circulardelivery device 3000, according to another embodiment. As shown, thedelivery device 3000 can comprise a shaft 3002 comprising a “D”-shapedcross-sectional profile.

Using a non-circular delivery device (e.g., devices 2900, 3000) with anon-circular prosthetic device (a prosthetic device having anon-circular cross-sectional profile in a plane perpendicular to thelongitudinal axis of the prosthetic device) can advantageously, forexample, allow for more controlled deployment due to more uniformdeployment forces. For example, pairing an elliptically-shapedprosthesis with an elliptically-shaped delivery system allows thedeployment forces to be more uniform in the radial direction withrespect to the circumference of the prosthesis. This uniformity can, forexample, provide more predictability and thus control during adeployment procedure.

It should be noted that the delivery devices 2900, 3000 can, forexample, comprise a non-circular catheter and/or a non-circular deliverysheath. It should also be noted that delivery devices 2900, 3000 can beused, for example, with both circular and non-circular implantableprosthetic devices.

FIGS. 114-127F show various embodiments of implantable prostheticdevices that have supplemental anchoring members to enhance theengagement of the anchors of the device against native leaflets.

FIG. 114 shows a prosthetic device 3100 comprising an annular main body3102 and anchors 3104 extending from the main body. Pieces offriction-enhancing material 3106 can be mounted on the outside of themain body 3102 at locations opposite the anchors 3104. In particularembodiments, the friction-enhancing material 3106 can comprise, forexample, the plastic hook material of a hook-and-loop fastener (e.g.,Velcro®). When implanted within a native valve, the anchors 3104 cancompress the native leaflets against the friction-enhancing material3106, enhancing the retention force of the anchors. In the illustratedembodiment, the friction-enhancing material 3106 is shown mounted (e.g.,with sutures) directly to the frame of the main body. In particularembodiments, the main body can be covered with a blood-impermeable cover(e.g., a fabric) and the friction-enhancing material 3106 can be mountedon the outside of the cover.

FIG. 115 shows a prosthetic device 3200 comprising an annular main body3202, a fabric cover 3204, and anchors 3104 extending from the mainbody. Mounted on each anchor 3206 can be one or more projections 3208formed of suture material wrapped around the anchor, glue or otheradhesive applied to the anchor, or a bead or ball of polymeric materialmolded or otherwise secured to the anchor. When implanted within anative valve, the anchors 3206 can urge the projections 3208 against thenative leaflets, enhancing the retention force of the anchors.

FIG. 116 shows a prosthetic device 3300 comprising an annular main body3302, a fabric cover 3304, and anchors 3306 extending from the mainbody. Mounted on each anchor 3306 can be one or more projections 3308formed of metal wire secured to the ends of the anchor. When implantedwithin a native valve, the anchors 3306 can urge the projections 3308against the native leaflets 3308, enhancing the retention force of theanchors.

FIG. 117 shows an exemplary anchor 3400 that can be secured to the mainbody of a prosthetic device (any of the prosthetic devices disclosedherein). The anchor 3400 can comprise one or more barbs or projections3402 that can engage, and optionally penetrate a leaflet when implanted,enhancing the retention force of the anchor.

FIG. 118 shows a prosthetic device 3500 comprising an annular main body3502, a fabric cover 3504, and anchors 3506 extending from the mainbody. Mounted on the frame of the main body can be one or more barbs orprojections 3508 that extend through the cover 3504. When implantedwithin a native valve, the anchors 3506 can compress the native leafletsagainst the projections 3508 (which can optionally penetrate theleaflets), enhancing the retention force of the anchors.

FIGS. 119A-119F show a prosthetic device 3600 comprising an annular mainbody 3602, a fabric cover (not shown), and anchors 3604 extending fromthe main body. The ends of each anchor 3604 can be coupled to respectivestruts of the main body 3602 by respective sleeves 3606 that can becrimped around the end portions of the anchor and the struts of the mainbody. Mounted on the frame of the main body can be one or more barbs orprojections 3608. The free ends of the projections 3608 in theillustrated embodiment are configured to reside generally within themain body and do not necessarily extend through the fabric cover (as isshown in FIG. 118). Nonetheless, the projections 3608 can exert aretaining force against the native leaflets by virtue of the anchors3604, which are shaped to force the native leaflets inwardly into themain body in the area below the free ends of the anchors 3604 when theanchors are moved from an open position (FIGS. 119E and 119F) to aclosed position (FIGS. 119A-119D).

FIGS. 120A-120C show a prosthetic device 3700 comprising an annular mainbody 3702, a fabric cover (not shown), anchors 3704 extending from themain body, sleeves 3706 coupling the anchors to the main body, andprojections 3708 extending from the main body. The device 3700 issimilar to device 3600 except that the anchors 3704 compriseintermediate portions 3710 that are shaped to extend inwardly into thearea below the projections 3708 when the anchors are in the closedposition, as shown in the figures. In this manner, the intermediateportions 3710 assist in pushing the native leaflets inwardly against theprojections 3710, thereby enhancing the engagement of the device withinthe native leaflets.

FIGS. 121A-121D show a prosthetic device 3800 comprising an annular mainbody 3802, a fabric cover (not shown), anchors 3804 extending from themain body, sleeves 3806 coupling the anchors to the main body, andprojections 3808 extending from the main body. The anchors 3804 compriseintermediate portions 3810 that press the native leaflets inwardlyagainst the projections 3808 and outwardly extending projections 3812that press the native leaflets against the main body in the area abovethe projections. The opposing lower legs of the anchors 3804 in theillustrated embodiment comprise coil springs 3814 that function asspring hinges that allow the anchors to be splayed apart from the mainbody yet provide a spring force that biases the anchors against the bodywhen the opening force is removed from the anchors.

FIGS. 122A-122D show a prosthetic device 3900 comprising an annular mainbody 3902, a fabric cover (not shown), anchors 3904 extending from themain body, sleeves 3906 coupling the anchors to the main body, andprojections 3908 extending from the main body. Similar to device 3800,the lower legs of the anchors 3904 can comprise coil springs 3814 thatfunction as spring hinges for opening and closing the anchors. Unlikeprevious embodiments, the projections 3908 extend radially outwardly anddownwardly toward the ventricular end of the main body and are mountedon outwardly curved strut members 3916 of the main body that protrudeoutwardly through the anchors 3908 when pivoted to the closed position.

FIGS. 123A-123D show a prosthetic device 4000 comprising an annular mainbody 4002, a fabric cover (not shown), anchors 4004 extending from themain body, sleeves 4006 coupling the anchors to the main body, andprojections 4008 extending from the main body. The anchors 4004 compriseintermediate portions 4010 that press the native leaflets inwardlyagainst the projections 4008 and outwardly extending projections 4012that press the native leaflets against the main body in the area abovethe projections. The opposing lower legs of the anchors 4004 in theillustrated embodiment comprise coil springs 4014 that function asspring hinges for opening and closing the anchors. The device 4000 issimilar to the device 3800 except that each of the springs 4014 has arespective end portion 4016 that extends upwardly from a coil portion4018 and curves back downwardly where it is connected to a strut of themain body by one or more sleeves 4006. FIGS. 124A-124F are various viewsthe device 4000 showing the anchors in the closed position (FIG. 124A),in the fully open position (FIG. 124D), and various partially openedpositions (FIGS. 124B-124C, 124E, and 124F).

FIGS. 125A-125E show a prosthetic device 4100 comprising a generallyspherical or bulbous main body 4102, anchors 4104 coupled to the mainbody, and projections 4106 extending outwardly from the main body. Inparticular embodiments, the main body 4102 and the anchors 4104 cancomprise a braided or weaved structure, such as a metal braid or weave,as described in embodiments above. As best shown in FIG. 125E (whichshows the anchors in a partially deployed position), each anchor 4104comprises a first foldable portion 4108 having one end connected to theventricular end of the main body and a second foldable portion 4110having one end connected to a lower ring 4112. When the device 4100 isfully deployed, the foldable portions 4108, 4110 are folded upwardlyalongside the main body 4102 such that the native leaflets are capturedbetween the main body and the foldable portions 4108 with theprojections 4106 engaging the native leaflets. As shown in FIGS.125A-125D, the ring 4112 is moved upwardly around the lower end portionsof foldable portions 4108, 4110 to resist movement of the anchors awayfrom the closed position, thereby retaining the device in place againstthe native leaflets. Although not shown, the anchors can be completelyunfolded to a delivery configuration by moving the ring 4212 furtheraxially away from the main body 4202 relative to the partially foldedstub shown in FIG. 126A.

FIGS. 126A-126J show a prosthetic device 4200. The device 4200 issimilar to the device 4100 in that it includes a generally spherical orbulbous main body 4202 and anchors 4204 coupled to the main body. Themain body 4202 and the anchors 4204 can comprise a braided or weavedstructure, such as a metal braid or weave, as described in embodimentsabove. Each anchor 4204 can comprise a first foldable portion 4208having one end connected to the ventricular end of the main body and asecond foldable portion 4210 having one end connected to a lower ring4212. Unlike the device 4100, the projections 4206 are mounted to theinner surfaces of the second foldable portions 4210 and the firstfoldable portions 4208 can be formed with slots or openings 4214 thatallow the projections 4206 to extend through the openings and engage thenative leaflets when the anchors 4204 are moved to the closed, fullydeployed position. FIG. 126A shows the anchors 4204 in a partiallydeployed state in which the anchors are partially folded. FIG. 126Bshows a detail view of a portion of the main body 4202, as indicated inFIG. 126A. FIGS. 126C-126F show the anchors in a further partiallydeployed state in which the anchors are further folded from the positionshown in FIG. 126A. FIGS. 126G-126J show the anchors in a fullydeployed, folded and closed state alongside the main body 4202 with theprojections 4206 extending through the openings in the first foldableportions 4208 to engage the native leaflets.

FIGS. 127A-127F show a prosthetic device 4300. The device 4300 issimilar to the device 4100 in that it includes a generally spherical orbulbous main body 4302 and anchors 4304 coupled to the main body. Themain body 4302 and the anchors 4304 can comprise a braided or weavedstructure, such as a metal braid or weave, as described in embodimentsabove and as best shown in FIGS. 127E and 127F. The device 4300comprises a lower ring or sleeve 4312. Each anchor 4304 can comprise afirst, inner foldable portion 4308 that is connected at one end to thelower end 4314 of the main body 4302 and a second, outer foldableportion 4310 that is connected at one end to the upper end 4316 of thelower ring 4212. The first foldable portion 4308 extends upwardly fromthe lower end 4314 of the main body 4302, through an opening in thesecond foldable portion 4310, and then curves outwardly and downwardlywhere it is connected to the upper end of the second foldable portion4310.

During delivery the lower sleeve 4312 is spaced from the main body suchthat the lower sleeve does not overlap the anchors and the foldableportions of the anchors are folded away from the main body (similar toFIG. 126A). As the device is deployed, the native leaflets are placed onopposite sides of the main body, and the anchors are folded upwardlytoward the main body to the fully deployed position (FIG. 127A) in whichto the native leaflets are engaged between the main body 4302 and thefirst foldable portions 4308. Folding of the anchors causes the sleeve4312 to be pulled over the lower end portions of the first foldableportions 4308 to retain the anchors in the fully deployed position.

By incorporating the supplemental anchoring members as shown in FIGS.114-127F, the structural components of the prosthetic device (e.g., themetal frame of the main body and/or the anchors) can be made relativelythinner and/or more flexible. As a result, the device is more easilycrimped for loading into a delivery sheath and exhibits greaterflexibility for tracking through small radius turns as it is advancedtoward the implantation site.

FIG. 128 shows an alternative embodiment of a steering control mechanism4400 that can be incorporated in any of the delivery devices describedabove (e.g., delivery device 1300) to control the deflection of thedistal end portion of the delivery device. The control mechanism 4400comprises in the illustrated embodiment a proximal control knob 4402 a,a distal control knob 4402 b, first and second shafts 4404 a, 4404 b,respectively, operatively coupled to the proximal control knob 4402 a,and third and fourth shafts 4404 c, 4404 d, respectively, operativelycoupled to the distal control knob 4402 b. A housing 4410 (illustratedas transparent in FIG. 128) can house the shafts, and the control knobscan be movably coupled to the housing 4410.

The first and second shafts 4404 a, 4404 b are coupled to the proximalcontrol knob 4402 a by respective gears 4406 a mounted on the proximalends of the shafts. The third and fourth shafts 4404 c, 4404 d arecoupled to the distal control knob 4402 b by respective gears 4406 bmounted on the proximal ends of the shafts. In this manner, rotation ofthe proximal control knob 4402 a causes corresponding rotationalmovement of the first and second shafts 4404 a, 4404 b, and rotation ofthe distal control knob 4402 b causes corresponding rotational movementof the third and fourth shafts 4404 c, 4404 d.

Mounted on the shafts are respective pull wire retainers 4408 a, 4408 b,4408 c, and 4408 d. The proximal ends of four pull wires (not shown) arefixedly secured to the pull wire retainers. Each of the pull wireretainers 4408 a, 4408 b, 4408 c, 4408 d have internal threads thatengage externals threads of their respective shafts 4404 a, 4404 b, 4404c, 4404 d and are fixed against rotational movement such that rotationof the shafts cause the pull wire retainers to move axially along theshafts upon rotational movement of the control knobs 4402 a, 4402 b, Thefirst and second shafts 4404 a, 4404 b are threaded in oppositedirections, while the third and fourth shafts 4404 c, 4404 d arethreaded in opposite directions. In this manner, rotation of theproximal control knob 4402 a causes the pull wire retainers 4408 a, 4408b to move axially in opposite directions and rotation of the distalcontrol knob 4402 b causes the pull wire retainers 4408 c, 4408 d tomove axially in opposite directions.

For example, if proximal control knob 4402 a is rotated to move thefirst pull wire retainer 4408 a proximally and the second pull wireretainer 4408 b distally, the pull wire attached to the first pull wireretainer 4408 a is tensioned and the pull wire attached to the secondpull wire retainer is slackened, causing the delivery device to bend ordeflect under the tension of the pull wire attached to the first pullwire retainer (upwardly in the illustrated embodiment). Conversely,rotating the proximal control in the opposite direction will causes thedelivery device to deflect under the tension of the pull wire attachedto the second pull wire retainer 4408 b (downwardly in the illustratedembodiment). Similarly, rotating the distal control knob 4402 b causesthe delivery device to deflect sideways to the left or the right underthe tension of the pull wire attached to the pull wire retainer 4408 cor 4408 d, depending upon the direction of rotation of the distalcontrol knob. Rotation of both the proximal and distal control knobs4402 a, 4402 b causes the delivery device to deflect under the tensionof two of the pull wires. Thus, as can be appreciated, the deliverydevice can be deflected upwardly, downwardly, sideways (to the left orthe right), or in any direction in between (e.g., downwardly to the leftor the right or upwardly to the left or the right).

FIGS. 129-130 show an exemplary embodiment of an implantable prostheticdevice 4500, similar to the prosthetic device 600. The prosthetic device4500 can comprise a spacer body 4502, a plurality of anchors 4504 (e.g.,two in the illustrated embodiment), a plurality of securing members 4506(e.g., two in the illustrated embodiment) and a locking element 4508. Asbest shown in FIG. 129 (which shows the prosthetic device 4500 in aradially compressed configuration), proximal end portions 4510 of theanchors 4504 can be coupled to the spacer body 4502, and distal endportions 4512 of the anchors 4504 can be coupled to the locking element4508. Proximal end portions 4514 of the securing members 4506 can becoupled to the proximal end portions 4510 of the anchors 4504, and thesecuring members 4506 can extend distally from the proximal end portions4514 to free, distal end portions 4516 of the securing members 4506.

In other embodiments, the prosthetic device 4500 can comprise greater orfewer anchors 4504 and/or securing members 4506. For example, in someembodiments, the prosthetic device 4500 can comprise three anchors 4504and three securing members 4506. In some embodiments, the number ofsecuring members 4506 can be less than or greater than the number ofanchors 4504.

As shown, the spacer body 4502, the anchors 4504, and/or the lockingelement 4508 can, for example, be formed from a braided material. Insuch embodiments, the spacer body 4502, the anchors 4504, and/or thelocking element 4508 can be covered with a blood-impervious materialand/or coating.

In some embodiments, two or more of the spacer body 4502, the anchors4504, and/or the locking element 4508 can be formed from a singleunitary piece of material. In other embodiments, the spacer body 4502,the anchors 4504, and/or the locking element 4508 can be formed fromseparate piece of material that are coupled together (e.g., by welding,an adhesive, fasteners, etc.).

The spacer body 4502 of the prosthetic device 4500 can be configured toreduce and/or prevent regurgitation between native heart valve leaflets(e.g., native mitral valve leaflets) in a manner similar the spacer body612 of the prosthetic device 600.

As noted above, the anchors 4504 can comprise the proximal and distalend portions 4510, 4512. The anchors 4504 of the prosthetic device 4500can also each include a joint portion 4518 disposed between a respectiveproximal and distal end portion 4510, 4512. As such, the anchors 4504can be configured to move from a first configuration (e.g., a resting orundeflected configuration, as shown in FIG. 129) to a secondconfiguration (e.g., a deflected configuration, as shown in FIG. 130),and vice versa, by pivoting at the joint portions 4118 with a deliveryapparatus (not shown) (e.g., similar to the manner in which the anchors610 of the prosthetic device 600 can bend at the joints 618 using thedelivery apparatus, as shown in FIGS. 27-34).

As also noted above, the securing members 4506 can include the proximaland distal end portions 4514, 4516. The securing members 4506 can alsoeach include a hinge portion 4520 and a plurality of projections 4522.The hinge portions 4520 can be disposed between the proximal and distalend portions 4514, 4516. The projections 4522 can be coupled to andextend radially (i.e., radially outwardly as depicted in FIG. 129 andradially inwardly as depicted in FIG. 130) from the distal end portions4516.

The securing members 4506 can be configured to pivot at the hingeportions 4520 such that the delivery apparatus can be used to move thesecuring members 4506 from a first configuration (e.g., a resting orundeflected configuration, as shown in FIG. 129) to a secondconfiguration (e.g., a compressed configuration, as shown in FIG. 130),and vice versa, as further described below.

In the first configuration, the securing members 4506 can be angled atthe hinge portions 4520 such that the projections 4522 of the securingmembers 4506 do not extend into and/or through the respective proximalend portions 4510 of the anchors 4504. In other words, the projections4522 are disposed radially inwardly (i.e., as depicted in FIG. 129)relative to the proximal end portions 4510 of the anchors 4504. Thisconfiguration can reduce and/or prevent the projections 4522 of thesecuring members 4506 from engaging (e.g., snagging) a delivery cylinderof a delivery apparatus (not shown) and/or a patient's native tissue(not shown) as the prosthetic device 4500 is loaded, positioned, and/orrecaptured (e.g., during an implantation procedure).

This can be accomplished, for example, by forming the securing members4506 from a relatively elastic material (e.g., Nitinol) andshape-setting the securing members 4506 such that an angle between theproximal and distal end portions 4514, 4516 at the hinge portions 4520is less than about 180 degrees. In some embodiments, the angle can beabout 135 degrees to about 175 degrees, and in one particularembodiment, the angle can be about 155 degrees.

As noted above, the securing members 4506 can be moved from the firstconfiguration to the second configuration using the delivery apparatus.The delivery apparatus can axially move the locking element 4508 and thespacer body 4502 toward each other such that the anchors 4504 pivot atthe joints 4518 and the locking element 4508 slides over and radiallyoverlaps the securing members 4506 at and/or distal to the hingeportions 4520 of the securing members 4506, as shown in FIG. 130. Thelocking element 4508 and the securing members 4506 can be configuredsuch that the locking element 4508 presses against the securing members4506, thus causing the securing members 4506 to pivot radially inwardlyat the hinge portions 4520 to the second configuration, as shown in FIG.130. The locking element 4508 can be configured to slightly radiallyexpand as it is slid over the securing members 4506 when moved to thesecond configuration.

In the second configuration, the securing members 4506 can be angled atthe hinge portions 4520 such that the projections 4522 at distal endportions 4516 of the securing members 4506 extend into and through therespective proximal end portions 4510 of the anchors 4504, as shown inFIG. 130. In other words, the projections 4522 can extend radiallyinwardly (i.e., as depicted in FIG. 130) beyond the proximal endportions 4510 of the anchors 4504. This configuration allows theprojections 4522 to engage native tissue to secure the prosthetic device4500 at an implantation location. For example, the projections 4522 canengage and/or penetrate native leaflets that are disposed radiallybetween the spacer body 4502 and the anchors 4504 (e.g., similar to thepositioning of prosthetic device 300 shown in FIG. 17).

Once the prosthetic device 4500 is desirably positioned, the lockingelement 4508 can be secured relative to the spacer body 4502, theanchors 4504, and the securing members 4506. This secures the prostheticdevice 4500 relative to the native tissue. The prosthetic device 4500can then be released from the delivery apparatus by actuating thedelivery apparatus.

Prior to releasing the prosthetic device 4500, the prosthetic device4500 can be repositioned and/or retrieved with the delivery apparatus bymoving the locking element 4508 relative to the securing members 4506such that the locking element 4508 is axially separated from thesecuring members 4506. This allows the securing members 4506 todisengage the native tissue and to move from the second configurationback to the first position. The prosthetic device can then be movedrelative to the native tissue and/or retrieved into the deliverycylinder of the delivery apparatus with a reduced likelihood that theprojections 4522 will engage native tissue and/or the delivery cylinder.

Prosthetic Valves

FIGS. 131-133 show an exemplary embodiment of a prosthetic heart valve4600. The prosthetic valve 100 can comprise a stent or frame 4602 (FIG.133), a leaflet assembly 4604 supported by and secured inside the frame4602 and a cover 4606 covering portions of the frame 4602. The leafletassembly 4604 can comprise one or more tissue leaflets 4608 (three inthe illustrated embodiment) made of biological material (e.g.,pericardial tissue, such as bovine, porcine or equine pericardialtissue) or synthetic material (e.g., polyurethane). The leaflets 4608are configured to allow blood to flow through the prosthetic valve 4600in one direction and block the flow of blood in the opposite direction.In FIG. 131, the leaflets 4608 are shown in solid lines, depicting theclosed position for blocking the flow of blood, and in dashed lines,depicting the open position allowing blood to flow through theprosthetic valve 4600.

FIG. 133 shows the frame 4602 without the leaflet assembly 4604 or cover4604. The frame 4602 can comprise an annular main body 4610 (whichhouses the leaflet assembly 4604), one or more first anchors 4612extending from one end of the main body 4610, and one or more secondanchors 4614 extending from the opposite end of the main body 4610. Inthe illustrated example, the prosthetic valve 4600 comprises aprosthetic mitral valve that is implantable in the native mitral valveannulus, the first anchors 4612 comprise ventricular anchors that aredeployed behind the native mitral valve leaflets within the leftventricle, and the second anchors 4614 comprise atrial anchors that aredeployed against the native mitral valve annulus within the leftventricle. The illustrated prosthetic mitral valve 4600 comprises twoventricular anchors 4612 positioned on diametrically opposite sides ofoutflow end of the main body 4610 and twelve atrial anchors 4614. Inother embodiments, the prosthetic valve 4600 can include greater orfewer number of ventricular anchors 4612 and/or atrial anchors 4614.

The frame 4602 can comprise a shape-memory material, such as nitinol (anickel-titanium alloy) for example, to enable self-expansion from aradially compressed state to an expanded state. Although not shown, whenconstructed of a self-expanding material, the prosthetic valve 4600 canbe crimped to the radially compressed state using the crimping apparatusand loaded into a sheath of a delivery catheter for delivery to animplantation site. When released from the sheath, the prosthetic valve4600 can self-expand to the expanded state at the implantation site(e.g., the native mitral valve). In alternative embodiments, the frame4602 can be plastically expandable from a radially compressed state toan expanded state by an expansion device, such as an inflatable balloon(not shown), for example. Such plastically expandable frames cancomprise stainless steel, chromium alloys, and/or other suitablematerials. When constructed of a plastically expandable material, theprosthetic valve 4600 can be crimped using the crimping apparatus to aradially compressed state onto or adjacent a balloon (or other expansiondevice) of a delivery catheter. Additional details regarding crimpingthe prosthetic heart valve 4600 and crimping devices can be found, forexample, in U.S. Patent Application Publication No. 2015/0336150 A1,which is incorporated herein by reference in its entirety.

The cover 4606 can comprise a blood-impermeable fabric and can extendover the outside of the main body 4610, the atrial anchors 4614, and/orportions of the ventricular anchors 4612. The fabric can comprise apolyester material, such as polyethylene terephthalate (PET).Alternatively, the cover can comprise biological matter, such aspericardial tissue or other biological tissue. Further details of theprosthetic valve 4600, for example, construction and assembly, aredisclosed in U.S. Pat. No. 8,449,599 and U.S. Patent ApplicationPublication No. 2014/0222136.

In the expanded state, the ventricular anchors 4612 extend along theouter surface of the main body 4610. Thus, once implanted at the nativemitral valve, the native mitral valve leaflets can be captured betweenthe main body 4610 and ventricular anchors 4612, thereby anchoring theprosthetic valve 4600 in place against systolic pressure in the leftventricle. The atrial anchors 4614 extend axially and radially outwardlyfrom the inflow end of the main body 4610. Thus, once implanted at thenative mitral valve, the atrial anchors 4614 can be disposed in the leftatrium against the native mitral valve annulus, thereby anchoring theprosthetic valve 4600 in place against diastolic pressure in the leftventricle.

FIGS. 134-135 show a frame 4700 for a prosthetic heart valve. The frame4700 can be configured similar to the frame 4602 of the prosthetic heartvalve 4600 (e.g., for implantation in a native mitral valve annulus) andcan, for example, be used with the leaflet assembly 4604 and the cover4606 of the prosthetic heart valve 4600. The frame 4700 can comprise anannular main body 4702, one or more first anchors 4704 (e.g., two in theillustrated embodiment 4704 a, 4704 b, collectively referred to hereinas “the first anchors 4704”) extending from one end of the main body4702, and one or more second anchors 4706 (e.g., twelve in theillustrated embodiment) extending from the opposite end of the main body4702.

In some embodiments, the first anchors 4704 can be coupled to the mainbody 4702 with a plurality of tabs or sleeves 4708 (e.g., two in theillustrated embodiment 4708 a, 4708 b, collectively referred to hereinas “the tabs 4708”). The tabs 4708 can be coupled to and/or extend froma first end 4710 (e.g., an outflow end) of the main body 4702 (e.g., onapices or junctions 4716 where two struts of the frame 4700 conictogether at the frame outflow) and positioned on diametrically oppositesides of the main body 4702 relative to each other. The tabs 4708 can beconfigured to securely receive end portions of the first anchors 4704.As best shown in FIG. 134, the tab 4708 a can securely receive first endportions 4712 a, 4712 b of the respective first anchors 4704 a, 4704 b,and the tab 4708 b can securely receive second end portions 4714 a, 4714b of the respective first anchors 4704 a, 4704 b. The tabs 4708 can becrimped and/or welded to the end portions of the first anchors 4704 andthe apices 4716 to enhance the connection between the first anchors 4704and the main body 4702 of the frame 4700.

Configuring the frame 4700 such that the first anchors 4704 share thetabs 4708 at the first and second end portions 4712, 4714 of the firstanchors 4704 advantageously balances the first anchors 4704 relative tothe main body 4702. As such, forces that are exerted on the firstanchors 4704 during the dynamic heart cycles tend to be equal andopposite of each other, thus canceling each other. This can reduceand/or eliminate the forces that are transferred from the anchors 4704to the main body 4702 and, thus, reduce and/or prevent the main body4702 from deflecting radially inwardly at the first end 4710 during thedynamic heart cycles.

The first anchors 4704 can be configured to pivot 180 degrees relativeto the main body 4702 from a functional configuration (e.g., FIGS.134-135) to a compressed, delivery configuration (not shown and viceversa. In the delivery configuration, the first anchors 4704 can extendaxially away from the second anchors 4706, as opposed to toward thesecond 4706 as shown in FIGS. 134-135. As such, the first anchors 4704do not increase the radial profile of the frame 4700 because the firstanchors 4704 do not radially overlap with the main body 4702. This canbe accomplished, for example, by forming the first anchors 4704 from arelatively flexible material such as Nitinol, stainless steel, and/orchromium alloys. A prosthetic valve comprising the frame 4700 can bedelivered using a delivery apparatus, such as disclosed in U.S. PatentApplication Publication No. 2014/0222136, which can be configured tocontrol pivoting movement of the first anchors 4704 between the deliveryconfiguration and the functional configuration with the native leafletscaptured between the anchors of the main body.

The geometry of the first anchors 4704 can comprise variousconfigurations. For example, the shape, the dimensions, etc. can beconfigured for a particular implantation location (e.g., the nativemitral, aortic, pulmonary, and/or tricuspid valve) and/or for a desiredcrimped and/or functional radial profile.

In other embodiments, the frame 4700 can include greater or fewer numberof first anchors 4704 and/or second anchors 4706. For example, the frame4700 can include three first anchors 4704.

General Considerations

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatuses, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, apparatuses, and systems are not limited toany specific aspect or feature or combination thereof, nor do thedisclosed embodiments require that any one or more specific advantagesbe present or problems be solved.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods. Asused herein, the terms “a”, “an” and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “Band C” or “A, B and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims. We thereforeclaim as our invention all that comes within the scope and spirit ofthese claims.

We claim:
 1. An implantable prosthetic device, comprising: a spacer bodyportion configured to be disposed between native leaflets of a heart,wherein the spacer body portion has a first end portion, a second endportion, and a longitudinal axis extending from the first end portion tothe second end portion, wherein the spacer body portion is configured torestrict antegrade blood flow through the spacer body portion from thefirst end portion to the second end portion and to restrict retrogradeblood flow through the spacer body portion from the second end portionto the first end portion; an end member longitudinally spaced from andlongitudinally movable relative to the spacer body portion; and aplurality of anchor members, wherein each anchor member has a first endportion and a second end portion, wherein the first end portions of theanchor members are coupled to the second end portion of the spacer bodyportion, and wherein the second end portions of the anchor members arecoupled to the end member, wherein the plurality of anchor members eachcomprise a braided material, wherein the prosthetic device is movablebetween a compressed configuration, in which the spacer body portion isradially compressed and extends axially away from the anchor members,and an expanded configuration, in which the spacer body portion expandsradially outwardly relative to the compressed configuration and axiallyoverlaps at least a portion of the anchor members.
 2. The prostheticdevice of claim 1, wherein the anchor members are each configured tosecure a respective native leaflet against the spacer body portion. 3.The prosthetic device of claim 2, wherein the anchor members each have ajoint portion disposed between the first end portion and the second endportion, and wherein the first end portions are spaced relative to thesecond end portions in the compressed configuration and overlap with thesecond end portions in the expanded configuration.
 4. The prostheticdevice of claim 3, wherein the anchor members are configured to befoldable at the joint portions when the spacer body portion is movedrelative to the end member between the compressed configuration and theexpanded configuration.
 5. The prosthetic device of claim 4, wherein theanchor members are configured to fold at the joint portions from thecompressed configuration to the expanded configuration when the spacerbody portion is moved relatively closer to the end member, and theanchor members are configured to unfold at the joint portions from theexpanded configuration to the compressed configuration when the spacerbody portion is moved relatively farther from the end member.
 6. Theprosthetic device of claim 2, wherein the anchor members arelongitudinally movable relative to each other.
 7. The prosthetic deviceof claim 1, wherein the spacer body portion and the anchor members areformed from a single, unitary piece of braided material.
 8. Theprosthetic device of claim 7, wherein the braided material comprisesNitinol.
 9. The prosthetic device of claim 1, wherein the spacer bodyportion and the anchor members are self-expandable.
 10. The prostheticdevice of claim 1, wherein the prosthetic device is configured forimplantation in a native mitral valve and to reduce mitralregurgitation.
 11. The prosthetic device of claim 1, wherein the spacerbody portion comprises a frame and a cover, wherein the cover isdisposed over the frame and is configured to restrict antegrade bloodflow and retrograde blood flow through the frame between the first endportion and the second end portion along the longitudinal axis.
 12. Theprosthetic device of claim 1, wherein the spacer body portion comprisesa frame, and wherein the frame is coated with a sealant materialconfigured to restrict antegrade blood flow and retrograde blood flowthrough the frame between the first end portion and the second endportion along the longitudinal axis.
 13. An assembly, comprising: animplantable prosthetic device having a spacer body, an end memberaxially spaced from and axially movable relative to the spacer body, anda plurality of anchor each comprising a braided material, wherein thespacer body has a first end portion, a second end portion, and alongitudinal axis extending from the first end portion to the second endportion, wherein the spacer body is configured to restrict antegradeblood flow through the spacer body from the first end portion to thesecond end portion and to restrict retrograde blood flow through thespacer body from the second end portion to the first end portion,wherein first end portions of the anchors are coupled to second endportion of the spacer body, and wherein second end portions of theanchors are coupled to the end member; and a delivery apparatus having afirst shaft and a second shaft, wherein the first shaft and the secondshaft are moveable relative to each other, wherein the end member isreleasably coupled to the first shaft, and the first end portion of thespacer body is releasably coupled to the second shaft, wherein thedelivery apparatus is configured such that moving the first shaft andthe second shaft relative to each moves the prosthetic device between afirst configuration, in which the spacer body is radially compressed andis longitudinally spaced relative to the anchors, and a secondconfiguration, in which the spacer body expands radially outwardlyrelative to the first configuration and the anchors at least partiallyoverlap the spacer body to capture native leaflets between the anchorsand the spacer body.
 14. The assembly of claim 13, wherein the firstshaft of the delivery apparatus extends longitudinally through thesecond shaft of the delivery apparatus and through the spacer body ofthe prosthetic device, and the first shaft is longitudinally movablerelative to the spacer body.
 15. The assembly of claim 13, wherein theanchors each have a joint portion disposed between the first end portionand the second end portion, and the first end portion is spaced relativeto the second end portion in the first configuration and overlaps withthe second end portion in the second configuration.
 16. The assembly ofclaim 15, wherein the anchors fold at the joint portions when the spacerbody is moved longitudinally relative to the end member.
 17. Theassembly of claim 16, wherein the anchors of the prosthetic device foldat the joint portions from the first configuration to the secondconfiguration when the spacer body moves relatively closer to the endmember longitudinally, and the anchors unfold at the joint portions fromthe second configuration to the first configuration when the spacer bodymoves relatively farther from the end member longitudinally.
 18. Theassembly of claim 13, wherein the prosthetic device further comprisessecuring members having barbs coupled to the anchors and configured toengage native leaflet tissue to secure the anchors to the nativeleaflets.
 19. A method of implanting a prosthetic device, comprising:advancing a prosthetic device in a compressed configuration to animplantation location using a delivery apparatus, wherein the prostheticdevice comprises a spacer body, an end member, a first anchor, and asecond anchor, each anchor comprising a braided material, wherein thespacer body has a first end portion, a second end portion, and alongitudinal axis extending from the first end portion to the second endportion, wherein the spacer body is configured to restrict antegradeblood flow through the spacer body from the first end portion to thesecond end portion and to restrict retrograde blood flow through thespacer body from the second end portion to the first end portion,wherein the end member is longitudinally spaced from and longitudinallymovable relative to the spacer body, and wherein the first anchor andthe second anchor each comprise a first end portion coupled to thesecond end portion of the spacer body and a second end portion coupledto the end member; radially expanding the prosthetic device from thecompressed configuration to an expanded configuration by actuating thedelivery apparatus to move the spacer body longitudinally relative tothe end member; capturing a first native leaflet against the firstanchor by actuating the delivery apparatus; capturing a second nativeleaflet against the second anchor by actuating the delivery apparatus;securing the first native leaflet and the second native leaflet againstthe spacer body of the prosthetic device by actuating the deliveryapparatus to move the first anchor and the second anchor relative to thespacer body so that each anchor at least partially overlaps the spacerbody; and releasing the prosthetic device from the delivery apparatus.20. The method of claim 19, wherein the act of capturing the firstnative leaflet occurs prior to the act of capturing the second nativeleaflet, and the act of capturing the second native leaflet occurs priorto the act of securing the first native leaflet and the second nativeleaflet against the spacer body of the prosthetic device.
 21. The methodof claim 19, wherein the act of capturing the first native leafletoccurs by actuating a first member of the delivery apparatus, and theact of capturing the second native leaflet occurs by actuating a secondmember of the delivery apparatus.
 22. The method of claim 19, whereinthe first native leaflet and the second native leaflet are securedagainst the spacer body of the prosthetic device by moving a first shaftof the delivery apparatus longitudinally relative to a second shaft ofthe delivery apparatus.